Medical Device ASIA, Jan-Feb 2015 issue

Medical Devices & Equipment | Healthcare | Pharmaceutical | Magazine

Vol.7 No.1 | January-February 2015 | New Delhi

www.medicaldeviceasia.in

fight Wrinkles!

Booming Global Market for HEALTHCARE! HEALTHCARE Fitness Watches!

Telehealth solutions!

EKF POC

hemoglobin analyzer!

3d

PRINTING MARKET

CMEF SHANGHAI

e

d i t

o r

i a l

highlights Medical Devices & Equipment | Healthcare | Pharmaceutical Journal Vol.7 No.1 | January-February 2015 | Annual Subscription: India: Rs.2000 ; Overseas: US$250

Managing Editor

Editorial Advisory Board

Sarvjit

Alex & Lilly - Netherlands

Associate Editor & Public Relations Director

Andy McCourt - Australia

Reny

Joint Editors

Vishwapreet Amrita

Production Rakesh

Marketing & Communications Lovleen

Web Editor Ravindar

Circulation Surekha

Secretary & Legal Advisor Surinder

China Correspondents

Ying Wei / Adrian Liu

alex@vanbienen.net UK Representative

Mike Steele, MJ Marketing

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Tel : +91 11 22141542 / 4309 4482 Fax: +91 11 22160635 Email: info@medicaldeviceasia.in Published, Printed and owned by: World-Wide Publications, D-182, PR House, Anand Vihar, New Delhi-110092, India and printed at Technical Press Inc. D-182, PR House, Anand Vihar, New Delhi 110092 - India.

The publisher does not necessarily agree with the views expressed by the

contributors, in this issue, nor do accept any responsibility for any errors or interpretation in the publication.

Union Budget 2015 A balanced roadmap for Medical Devices & Healthcare India is one of the most lucrative markets for medical devices globally. With the market relying largely on imports, the country provides significant opportunities for multinational medical device manufacturers. The domestic manufacturers are mostly engaged in low-value products like syringes, needles, catheters, blood collection tubes, medical electronics, medical equipment and implants.

The Indian medical devices market will benefit from the expansion of health insurance, which currently is the fastest growing non-life insurance segment in the country. Future growth in the medical devices market is also expected to be driven by patient demographics, particularly with the rise in the country’s aging population, which has fuelled increased incidence of age-related diseases, such as cardiovascular disease and Alzheimer’s disease.

Although the prospects for the market appear promising, the lack of strict regulation of several medical devices in the country will be a challenge in the future as the devices reaching the market become more complex and the endusers demand quality for the price.

India has experienced increased popularity in medical tourism as patients in developed nations become increasingly discouraged with local healthcare facilities, increasingly costly procedures and long waiting times. The Indian medical tourism market is growing at a double digit rate of 30% and is

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Worldwide 3D Printing Market to Grow 20.6% by 2020 STARLED1 EVO - MEDICAL LAMP Medical Technology Potentials Are Enormous Booming Global Market for Healthcare MEDICAL FAIR INDIA 2015 ECL 105/412- the latest revolution in Coagulation Analyzers diagnose your future illnesses POC hemoglobin analyzer Telehealth solutions Fitness Watches Fight Wrinkles with iDerma Can ultrasound detect potential heart attacks ?

New technology to detect lingering cancer cells Diagnostic screening: LASIK: A Fight FDA Can’t Ethically Win How ‘Noisy’ Data Is Holding Hospitals Back

expected to reach $2bn in size by 2015, according to industry estimates. Union Health Ministry will have its hands full in the next fiscal as the government has linked its ambitious cleanliness drive to hygiene and allocated Rs 33,150 crore for setting up AIIMS in various states.

The Health Ministry has been given an outlay of Rs 33,150 crore for 2015-16 in the budget as the government proposes to set up five AIIMS in Jammu and Kashmir, Himachal Pradesh, Punjab, Assam and Tamil Nadu and AIIMS-like institute in Bihar. “It will provide a quantum jump in health care in these states and the neighbouring areas. The Health Ministry will implement these in the shortest possible time,” Health Minister J P Nadda said.

The focus, he said, within the Budget on ‘Swachch Bharat’ and linking this with health care has broad-based health issues in the country. This will lead to greater awareness among the people regarding the importance of cleanliness, he said. Referring to the overall budgetary proposals, Nadda said it is balanced, progressive, pragmatic and pro-people, and “the budget will lead to all around social and economic development that is inclusive and outcome oriented.”

However, counting implementation of GST as a positive move, Claris Life-sciences Vice-Chairman & MD Arjun Handa said that the budget has given a good road map of not just the next year but also for the tenure of the government. And implementation of long awaited GST and bringing the corporate tax rate to 25 per cent would help in rationalising taxes. v

Medical Device ASIA | January-February 2015 | 3

Worldwide 3D Printing Market to Grow 20.6% by 2020 Analysts have forecast that the global 3D printing market will reach US$8.6 billion by 2020, with a CAGR of 20.6 per cent from 2014 to 2020. The growth is expected to come from increasing demand for the quick and more efficient manufacturing of complexly designed objects using a wide variety of materials.

A

dditive manufacturing (AM), commonly known as 3D printing, is now widely adopted across sectors from automotive to medical and even in food manufacturing.

Currently, the U.S. is the largest market in both production and consumption. In light of this trend, MTA2015 will be highlighting 3D printing technologies and solutions at the event. Mr. Sean Looi, General Manager of Creatz3D, a Singapore home-grown company providing 3D printing products and solutions, shared with MTA2015 his views on the growth potential of this technology in the Singapore market and beyond.

Growth of 3D printing in Singapore and Asia SL: If you Google, there’s a lot of hype of 3D printers/AM in the Asia region. For countries with high labour costs such as Singapore, AM can significantly help to drive productivity to achieve cost savings in the long run. There are many ways AM can support manufacturers in traditional processes. This can be done by examining the individual company’s current capabilities and how 3D printing/AM can assist in streamlining processes.

This is why we, Creatz3D, have been focused on building our application and technical support team in Singapore.

3D printing/AM has seen significant growth and adoption in Singapore in the past few years.

Traditionally, AM was applied in the area of prototyping for common applications such as Fit, Form and Function. More

recently, the growth of AM and its uses and applications have started to penetrate into areas related to manufacturing and as end use parts. However, Singapore manufacturers are still falling behind in accepting and adopting AM to complement traditional manufacturing process. AM can be applied across all sectors/ industries but what I view as a problem is the shift needed in the industry’s mind set, to accept AM as a complement to the business workflow rather than replace it.

3D printing a gimmick?

SL: Consumers have only seen products such as toys, jewellery, mobile phone cases etc. that have been 3D printed, hence I’m not surprised that they think of this technology as a fashion fad.

However, consumers do not see how AM has been implemented to change the way that products are designed and manufactured.

There’s a gap in the knowledge between users and consumers and education is the way to break this barrier. In my opinion, the only group of home based users that understand the benefits of AM are the engineers and makers that have seen the benefits of 3D printing or AM either at work or within their own community.

Staying power of 3D printing SL: I think many people would agree with me that professional 3D printers/AM Systems will be here to stay as there are significant benefits that we can harness. But we are still some time away to fully reaping the benefits of AM. Education in the area, specifically in “Design for Additive Manufacturing”, is

4 | January-February 2015 | Medical Device ASIA

currently being introduced in our educational institutes on a grander scale. I think when the shift in mind set is more prevalent in our economy, we can then truly see the benefit of AM.

Challenges for manufacturers SL: Singapore manufacturers have positioned themselves to provide high value added solutions to their customers and AM can further enforce this point. However, the main hurdle is the manufacturer’s willingness to try and adopt AM and use it across the organisation. Failure should be viewed positively so that manufacturers will have the courage to innovate to improve our daily lives.

Creatz3D will be showcasing 3D printers from Stratasys – one of the world’s most established manufacturers of 3D printing equipment and materials. In addition, the company will be highlighting 3D printed metal parts manufactured with the Electron Beam Melting (EBM) Technology from Arcam Equipments. Other exhibitors highlighting 3D printing equipment and technology from brands such as 3D Systems and Envisiontec include DKSH Technology, Eye-2-Eye Communications and FreeForm Solution.

MTA2015: High calibre manufacturing showcase MTA2015, Asia’s premier precision engineering industry event, will showcase high-value manufacturing capabilities, highlighting manufacturing Show:

excellence in industries such as Aerospace, Complex Equipment, Electronics, Medical Technology and Marine & Offshore Engineering. As manufacturing processes become more sophisticated and requirements for advanced research and development grow, MTA2015 is well-placed to provide the links between major industry players and suppliers across the value chain.

In recognition of the rising awareness and industry adoption of 3D printing, MTA2015 will be staging 3D Printing Technology Tours, to offer attendees an exclusive opportunity to see the technology in action through live demonstrations conducted by participating companies.

MetrologyAsia2015: Serving industry’s demands for precise measurements MetrologyAsia2015, an area dedicated to metrology equipment, will cast a spotlight on companies specialising in high-end test and measurement apparatuses and systems. Attendees will be exposed to the latest in metrology technology and equipment to meet their precision measuring needs.

MTA2015 will incorporate iAutomation2015, MetalAsia2015, Outsource&SubCon2015 and ToolTec2015, specialised events that cater to the individual needs of Asia’s manufacturing industry.

For more information, please visit www.mta-asia.com.

MTA2015 - The 20th Precision Engineering Industry Event (held alongside MetrologyAsia2015) Incorporating: iAutomation2015, MetalAsia2015, Outsource&SubCon2015, ToolTec2015 Date: 14 – 17 April 2015 (Tuesday - Friday) Venue: Singapore Expo, Halls 3 & 4A Opening Hours: 10.30am to 6pm daily Admission: Business and trade professionals Website: www.mta-asia.com Visitor registration: http://www.mta-asia.com/to-visit/visitor-pre-registration/

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It is a reliable product that assures excellent light intensity and low consumption (12W) at the same time.

Starled1 Evo has a functional design, is easy to move and its light head remains steady during its use once positioned. The lamp has a smooth and easy-to-clean surface to allow the best cleanliness. Its light beam is homogeneous and intense with 60.000 lux at 50 cm and producing a color temperature of 4.900 °K and a color rendering index (CRI) of 95.

The innovative I–SENSE® touch panel allows to adjust light intensity and select the desired light level according to the different needs.

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100-240 VAC– 50/60 Hz 12 VDC 12W 12 cm 1 kg 3 kg White RAL 9002

Medical Technology Potentials Are Enormous The Health Industry Summit (CMEF) in Shanghai opens path to Chinese market, features products for global distribution Is China still a key driver for world economy? Some market observers underline that growth in 2014 was down to 7.4 per cent – the lowest rate within 24 years. However, this change is well within the range of the central administration’s policy aiming at sustainable dynamics. And what is even more important for the medical technology sector: As of 2013, the Chinese medical technology market sported in excess of 24 billion US-$ and the world’s highest sector growth rate – 25.9 percent. By 2020, the administration aims to increase spending in the sector to approx. 1 trillion US-$. These impressive figures provide the perfect backdrop for Reed Sinopharm’s Health Industry Summit which beckons to medtech stakeholders from around the world this spring.

The current situation of China’s healthcare reform: According to results presented at the State Council of the People’s Republic on January 19, the envisaged basic system providing care to urban as well as rural regions has been established as planned. “The future target of the country’s healthcare reform is to optimize healthcare resources enabling residents to receive more effective prevention and clinical treatment while paying less money out of pocket”, explains the marketing manager of a large Chinese manufacturer who is active at a global level.

Budgets from the government: As a priority, the central government will re-enforce the services capability of county-level hospitals, and support implementing a standard of care for community healthcare institutions.

Furthermore, the administration is placing additional emphasis on strengthening medical IT infrastructure and telemedicine services.

Influences on the market: The strengthening of countylevel hospitals and community healthcare institutions will lead to increased demand for medical devices.

“Since the government aims at gradually implementing 8 | January-February 2015 | Medical Device ASIA

a system in which community healthcare institutions act as the patients’ first point of call for acute care, rehabilitation, and nursing services to reduce the number of outpatient cases in public hospitals, these institutions will need more diagnostic, rehabilitation, and hospital equipment”, according to the marketing manager.

Further drivers in the market: In addition, aims of the central administration include installing at least one hospital with comprehensive services and one traditional Chinese medicine (TCM) hospital in each county.

Also the government encourages the involvement of social capital in improving medical services, and creation of new non-profit healthcare institutions is encouraged based on the cooperation of social capital and public hospitals. The government will support those hospitals built with social capital to increase their number of beds.

Drivers of the medical devices market: In China, currently devices made by Chinese manufacturers are mainly sold to public hospitals below category III – which is the top hospital category in the country – and to private hospitals. However, some large innovative domestic manufacturers have been successful in entering the top category market thanks to their strong technical and financial resources, impinging on the monopoly of imported devices category III hospitals.

Regions make a difference: Due

to the unbalanced economic development in the various regions of China, healthcare resources mostly accumulate in the coastal areas, causing a large gap regarding medical technology and medical services skills between the coast, tier 1 cities, and the rural west of the country. In that rural area and parts of the underdeveloped provinces, medical equipment is generally used for a longer period without replacement. Much of the equipment is comparatively old, and penetration of high-end and valueadded imported devices is low. With the continuous large investment from both central and local administrations at the basic level of care, a larger number of county-level hospitals and community healthcare institutions will refurbish their infrastructure and purchase new medical equipment.

“As far as middle and high-level equipment is concerned, for various reasons Chinese hospitals still prefer to buy imports. Both domestic and imported medical equipment will have an opportunity to grow by a large extent in China in the upcoming years”, explains the manager.

High-end medical equipment used in China is mostly from foreign manufacturers; in the middle-high end range imports own 80% market share; in the middle to low end sector, imports have 40% while national manufacturers take 60% of the market, and low-end equipment used in China comes mostly from national manufacturers.

decision makers and end users where real trends are shaped, to institutions and R&D firms where the next big opportunities are defined. Ultimately, underlines Wang, the needs of the market and the technology benefits shape the opportunities of the market in China.

Features Chinese hospitals focus on: Research and development of medical equipment requires huge staff and financial resources, with the added difficulty of highly restricted access and IPR (intellectual property rights) protection similar to the pharmaceutical industry. According to the marketing manager, roughly 80% of the domestic manufacturers focus on producing low value-added medical disposables, general surgical instruments, rehabilitation equipment, home-use devices, and low-end diagnostic equipment. Products with high value are mainly imports, which leaves hospitals with little choice.

Summit to present this market information: From May 15 to 18 in Shanghai, the Health Industry Summit in Shanghai – previously under the name of China International Medical Equipment fair (CMEF) – will sport more than 100 conference sessions, with more than half focusing on various fields of medical technology and market trends. “The conference portfolio will include the China Integrated Medical Imaging Summit, the In-Vitro Diagnostics China Summit, and many more”, explains James Wang, marketing director of the Summit. The China Healthcare Investment Summit – the key conference – will focus on topics such as China’s Health Reform and Healthcare Service Development, New Trends in Health Industry Regulations, and the Creation of the Intelligent Healthcare Ecosystem, drawing top level participation as business leaders and investors contemplate the next big moves related to investing in the booming China health market, outlines Wang.

Entering the market: CMEF has long been the leading medical equipment event in Asia, Wang goes on to say. “While sourcing and trading activities may attract the crowds, however, it is for companies wishing to enter the Chinese market that CMEF plays a vital role: Finding the best partner and picking the right product suitable for the market makes all the difference between growing rapidly and losing out”. No other event in China provides a similar exposure to the thousands of key hospital

International players at the Summit: Over 3,000 suppliers and nearly all of the key players in the market are represented at the show – including, e.g. GE, Siemens, Philips, Mindray, Neusoft, Toshiba etc. – from the U.S., Japan, Europe, Asia Pacific, and of course China.

New set-up of the congress and tradeshow and investment environment: The Health Industry Summit combines the medical and pharmaceutical value chains into one mega event which explores a multitude of synergies including distribution, international trade, and investment opportunities.

“Investment in the health sector is on the rise, with 255 investments in the health sector in China worth 19.5 bn RMB from January to October 2014, representing a major

jump in growth compared to 5.3 bn RMB in 2013”, says Wang.

The event comes at the perfect time when China announces major investments and developments in the health sector, including in the health services and new technologies in health IT systems and digital health platforms. “In the context of the envisaged size of the health industry in the country at 8 trillion RMB by 2020, the central administration has made steps to speed up licensing and registration for health food and nutrition products as well as other international technologies in the medical and pharmaceutical fields.

Favourable tax policies on selected product imports are also on the agenda between key countries and China”, is Wang’s overview of trends.

International buyers: More than 10,000 international buyers from more than 140 countries will join the event. The health industry Summit will effectively combine the world’s largest integrated health expo (with 280,000 square metres of exhibition space and an estimated 200,000 visitors) with a full Summit program to help the health industry in China to link up with its international counterparts. The event looks to be a highly anticipated prelude for larger changes and greater things to come in the health sector and the worlds of medical technology and pharmaceuticals. v

About the Health Industry Summit Location: Shanghai, China Date: May 15 to 18 Focus: medical technology and pharmaceuticals Expected audience: 10,000 international buyers, 280,000 square metres of exhibition space, total 200,000 visitors) Further information: http://www.thishealthsummit.com/en/index.jhtml Medical Device ASIA | January-February 2015 | 9

Booming Global Market for Healthcare ith a record-breaking 240 exhibitors from 14 countries and regions in 2014, the success of HKTDC Hong Kong International Medical Devices and Supplies Fair reflects the burgeoning demand for quality equipment and supplies in both developed and emerging markets.

More than 9,600 buyers were keen to create relationships with reputable suppliers. Against this promising backdrop, the sixth Hong Kong International Medical Devices and Supplies Fair will run from 18-20 May 2015 at the world-class Hong Kong Convention and Exhibition Centre.

W

Hong Kong: Global Trading Hub The economic development of Asia

has underpinned a robust healthcare industry with new hospital developments, both public and private, a growing body of medical professionals in private practice, and an increasingly well-educated, affluent and health-conscious public.

Economies with well-established healthcare systems are constantly looking to upgrade facilities and maintain a technological edge.

There is no better place to serve their needs than Hong Kong, with its geographic advantage and its sophisticated commercial support.

It is close to markets showing great demand such as the Chinese mainland, where total sales of medical devices have grown continuously on the Chinese mainland for the past 13 years, with

10 | January-February 2015 | Medical Device ASIA

an average annual growth rate of above 20%.

Making the Right Connections Exhibitors of medical and healthrelated technology, equipment, devices and supplies, including consumables, will meet with healthcare decision-makers from worldwide healthcare authorities, clinics, aged care facilities, distributors and agents.

Major Theme Zones Theme zones are created to enhance buyers’ soucing experience.

Rehabilitation & Elderly Care Zone dispalys products such as patient monitoring devices, orthopaedic equipment, wheel

chairs and other mobility aids, etc.

Hospital Equipment Zone covers all aspects of hospital needs, including electro-medical equipment, ultrasound and imaging equipment, anaesthetic equipment and surgical instruments, etc.

Household Medical Products Zone houses all kinds of devices, usually portable, which now allow use of testing technology and fitness development equipment, development equipment, even treatment, in the home.

Physiotherapy Zone, new in 2014, returns in 2015, with the opportunity for exhibitors to showcase relevant products and devices.

Medical Cosmetology Zone continues to showcase a specialised platform for equipment including IPL (intense pulsed light) devices and laser devices for beauty and dermatology applications, etc.

Dental Equipment Zone, newly introduced in 2015, offers buyers with a wide range of equipment, devices and technology, including oral care products such as tooth floss, dental laser technology, operative burs and dentistry furniture, dentistry instruments, etc.

Tech Exchange is an exciting space for research institutions, product developers and entrepreneurs to show the fruits of their research and experimentation in the form of prototypes of medical devices and equipment.

Other product zones include Medical Supplies and Disposables, Manufacturing & Design Solutions, Laboratory Equipment and Building Technology and Hospital Furniture, etc.

Cross-event Synergy with the Hospital Authority Convention One of the region’s largest events, Hospital Authority Convention, is held concurrently. Over 4,000 delegates who are healthcare professionals will attend and hear from some 90 speakers over two days. Convention participants bring additional business and networking opportunities for exhibitors.

Market Intelligence and Product Familiarisation Seminars by expert speakers cover a diverse range of topics from technology updates, business opportunities in new markets and medical breakthroughs. Buyer Forums are presented by experienced buyers from different markets, updating the audience on the markets' status. Exhibitor Forums provide a daily opportunity for exhibitors to have close contact with groups of buyers to give them detailed product information.

Medical Device ASIA | January-February 2015 | 11

Exhibitors’ comments “Founded in Australia in 2005, Benson Medical has developed two products namely Snoreben© and MedAir©, which are designed to address the very common problem of chronic snoring and respiratory deficiency. I am introducing these two products to international buyers at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2014. Currently, these two products are sold in Australia, Canada, India, New Zealand and the US. My main objective of joining this fair for the first time is to look for distributors.

I am very happy with the results so far. For Snoreben©, I’ll sign an agreement with a distributor in Hong Kong soon and I have also found three other potential distributors from the Chinese mainland, India and Europe. For MedAir©, I have found two potential distributors from Hong Kong and Malaysia. I’ll definitely join this fair again next

year.”

Richard Benson, Director, Benson Medical Services Pty Ltd, Australia

here.”

Steve Parker, Expor t Director, Thesis Technology Products Ltd, the UK

“In business for 20 years, we are a UK company that designs and manufactures the LimbO waterproof protectors and outdoor protectors that provide waterproof protection for casts and dressings. Our products are sold not only in the UK but also in other European countries, the Americas, Australia and Japan. We have participated at this Medical Fair for the first time because we are keen to expand in the Asian market. It’s a good start for us.

Buyers’ Comments “Hospimetrix is an exclusive distributor of anaesthesia and respiratory products from leading brands for hospitals and intensive care units in Malaysia. It is my first visit to this Medical Fair. I am looking for unique products which are suitable for the Malaysian market and then explore the possibility of exclusive distributorship.

We have been busy meeting new people. Our waterproof protectors have attracted a lot of interest from Asian buyers including those from India, Malaysia, Singapore and Thailand. We have found about 30 potential distributors for this region.

We are pleased with the results

12 | January-February 2015 | Medical Device ASIA

At this fair, I have found interesting products such as disposable apparel and multi-function scales. I’ll have further discussion with the supplier of multi-function scales about the exclusive distributorship for the Malaysian market. The fair is well-organised.”

Ricky Teoh, Managing Director, Hospimetrix Sdn Bhd, Malaysia

“In business for 30 years, Emergencia 2000 is one of the leading sellers of emergency medical products. Apart from producing emergency medical products in our factories in Spain and Portugal, my company also imports items such as emergency chairs and health monitors from other countries.

It is my first time visiting this fair. I hope to make new contacts and find potential partnerships especially for the supply of first-aid equipment and emergency medicine.

It is interesting to know more about the market through this fair. With the help of the HKTDC business matching team, I have found four potential suppliers. It’s a wellorganised show with good customer service.”

Julian Rodriguez Fernandez, CEO, Emergencia 2000 S.A ., Spain

GENERAL INFORMATION FOR EXHIBITORS/ VISITORS/PRESS Fair Dates 18 May 2015 (Mon) 19 May 2015 (Tue) 20 May 2015 (Wed)

Opening Hours 10am–6pm 9:30am–6pm 9:30am–5pm

6th EDITION Buyer Registration Hours 9:30am–5:30pm 9am–5:30pm 9am–3:30pm

Venue : Halls 3F&G, Hong Kong Convention and Exhibition Centre, 1 Expo Drive, Wanchai, Hong Kong Admission : Free admission for trade visitors aged 18 or above only Organiser : Hong Kong Trade Development Council Co-organiser : Hong Kong Medical and Healthcare Device Industries Association

Major Exhibit Categories : • Accident and Emergency Equipment • Building Technology and Hospital Furniture • Chinese Medical Devices • Communication, Systems and Information Technology • Dental Equipment and Supplies • Diagnostics • Electromedical Equipment / Medical Technology • Laboratory Equipment • Medical Components and Materials • Medical Cosmetology • Medical Supplies and Disposables • Physiotherapy / Orthopaedic / Rehabilitation Technology • Medical Textiles • Trade Services and Publications

Visitor Profile : • Child Care Centres & Nurseries • Department stores / Chain stores / Supermarkets / Hypermarkets • Drugstore chains / Pharmacies • Hospitals: Medical & Dental • Importers, Agents, Distributors, Wholesalers & Retailers • Leading Pharmaceutical Companies • Medical Centres, Medical Chains, Clinics, Dental Clinics, School Dental Care • Centre & Chinese Medical Care Centres • Medical Laboratories • Medical Research Institutes, Medical Schools, Dental Schools • Nursing Homes & Elderly Homes • Physiotherapy Clinics • Public Authority: Health Authority & Hospital Authority • Rehabilitation Centres

For more information, please contact: Hong Kong Trade Development Council - Exhibitions Department Unit 13, Expo Galleria, Hong Kong Convention and Exhibition Centre, Wan Chai, Hong Kong Tel: (852) 2584 4333 Fax: (852) 2824 0026 E-mail: exhibitions@hktdc.org

Medical Device ASIA | January-February 2015 | 13

Liposuction: It a Procedure to Remove Stubborn Fat, Not For Weight Loss

L

iposuction or removal of excess fat from the body is a much talked about procedure in cosmetic industry today.

With greater exposure to the both national and international media, and with the mushrooming of several clinics who offer the procedure, general awareness about the same has grown in India. However, a lack of clear understanding about the procedure and misconceptions about the same are rampant.

Dr Mandeep Singh, Consultant Cosmetic & Plastic surgery, Paras Hospitals, Gurgaon

Since liposuction is a cosmetic procedure aimed at improving appearance, not a surgery required for health reasons, it is pertinent that people should know in detail about it. Proper awareness ensures that they make informed decisions about going for the procedure.

Is Liposuction a Weight Loss Procedure?

The simple answer is no. Liposuction should not be confused to be a weight loss procedure though the patient undergoing this treatment, may automatically lose some weight on account of fat loss. Liposuction is aimed at removing excessive fat from any area of the body, like the front of the abdomen or the sides of the abdomen, the thighs, the neck, buttocks and even face.

Bulges of fat are extremely common in human body. Indians are especially prone to accumulate fat on the tummy. Often, this is a result of our lazy lifestyle, lack of workout as well as fat-rich diet. However, sometimes, despite our best efforts with exercise and diet control, some areas refuse to lose fat.

So, while our overall weight would be under control, the stubborn fat on the side of the tummy or on the buttocks would refuse to burn. Liposuction is an ideal procedure to target such stubborn fat.

Liposuction as stated above is a procedure to remove small bulges of fat on various parts of the body that diet and exercise could not address. This helps bring the body in better shape which all areas having the right proportion of fat. It should be understood

14 | January-February 2015 | Medical Device ASIA

that liposuction does not remove cellulite.

How is it done?

As the name suggests lipo-suction involve suctioning or pumping out excess fat from a particular area of the body that has pockets of stubborn fat.

During the procedure, small and thin tube-like devices are inserted into small incisions made into the skin; and fat is suctioned out through the tubes in a targeted way.

The procedure is usually an outpatient procedure but the duration of your stay in the hospital may be determined by the location of the surgery or the amount of fat being removed. This will also determine whether you are administered local anesthesia or general anesthesia during the procedure.

Small cuts are made in the target area and fat is pumped out using a suction device or a large syringe.

There is a limit to the amount of fat that can be removed at on go, therefore it is suggested that people with average or a little more than average weight are ideal candidates for it. People with excessive weight are not ideal candidates and are not recommended a liposuction.

Moreover, liposuction should not be considered a weight loss procedure. It is a targeted fat removal procedure.

Its Variants Traditionally the liposuction surgery was done under general anesthesia, using small tubes to pump out fat from the desired area.

However, recent advances in the field have put forward better and easier options which are actively being used today. They do away with the need of general anesthesia,

hence eliminating the risks associated with it and making the procedure safer.

In what is called as tumescent liposuction, a local anesthesia is given to numb the target area and then an anesthetic solution is injected into the fatty tissue that is to be sucked out. The patient can remain awake throughout the solution. Similarly, in Laser Assisted Liposuction, low energy lasers are used to liquefy the fat in a targeted way. The liquefied fat is then easily removed using a small tube. In Ultrasound Assisted liposuction, on the other hand, ultrasound is used to liquefy the fat which makes it easier to remove then.

The later day advances have undoubtedly made liposuction a much safer and easier procedure.

However, a lot of care should be taken during recovery. While it is an outpatient procedure usually, complete recovery takes time as bandages have to be wrapped around firmly at the target areas.

Antibiotics have to be given to prevent infections, and care should be taken to support healing.

Strictly a Cosmetic Procedure: It should be remembered, however, that liposuction should not be considered a weight loss procedure.

It is aimed to help you get rid of fat bulges that give your body a poor shape. Liposuction is ideal for you if you have achieved a healthy body weight but are disappointed by stubborn fat that continues to cling on to your tummy or thighs.

For people with excessive weight or those with morbid obesity, there are other surgical options like bariatric surgery. v

IncorporatIng

12 - 13 May Prince Hotel and Residence | Kuala Lumpur, Malaysia Pre-conference Lean Focus Day: 11 May 2015 | Post-conference Workshops and Site Tour 14 May 2015

Featuring Speakers from Malaysia Ministry of Health, Singapore National Health Group and the Hong Kong Hospital Authority

Dr. Cheung Wai-lun, Allen Director (Cluster Services) Hospital Authority, Hong Kong

Dr. Feisul Idzwan Mustapha Public Health Physician, NonCommunicable Disease Section, Disease Control Division Ministry of Health, Malaysia

Dr. Nor Akma bt Yusuf Deputy Director, Hospital Management Services Unit Ministry Of Health Malaysia

Ho Khai Leng Group CIO National Healthcare Group, Singapore

Featured top Hospitals Include:

Brought to you by:

+65 6722 9388

Supporting partners:

enquiry@iqpc.com.sg

www.healthcareweekasia.com

MEDICAL FAIR INDIA 2015 TO GIVE A FILLIP TO INDIAN MEDICAL INDUSTRY 21st Edition of Medical Fair India 2015, the much awaited event for the Indian Medical Industry to take place from 21st-23rd March in Pragati Maidan, New Delhi Medical Fair India 2015, the most influential trade fair for medical products, pharmaceutical products, medical technological products and health care service facilities; in its 21st edition will showcase the latest technological advancements in a vastly diversified medical sector. Medical Fair India 2015 the flagship brand of Medica- the world’s largest annual medical event held in Düsseldorf, Germany. The event will be flagged off from March, the 21st to 23rd, 2015 at Pragati Maidan, New Delhi and would prove to be the bellwether amongst the medical events in the country. The current edition of Medical Fair India comes with a special focus on Hospital Infrastructure and planning, witnessing participation from over 20 countries with dedicated country pavilions from the U.S and the U.K, Germany, Taiwan, Korea, Belgium, China, Italy, Malaysia and Singapore.

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he event will have nearly 500 exhibitors from India and abroad showcasing their products and services which will help visitors to identify new providers, new agents and joint venture partners. It is aimed at sourcing out new products and technologies and to find new suppliers for stakeholders in the medical industry.

Medical Fair India 2015 will be attended by a wide spectrum of experts in the medical field like doctors, practicing physicians, veterinarian, dentists, physiotherapists, ergo-therapists. The visitor profile will also include professionals like hospital directors/ managers, hospital owners, hospital administration managers and staff, medical specialists and superintendents, service providers. Biologists, microbiologists, biochemists from the research community along with general service providers like process engineers, NGOs for rehabilitation aids, distributors, visitors from academics and universities and visitors from government and international agencies will also be a part of the event.

Medical Fair India 2015 will have special features like the co-inciding of the 5th edition of Medgate Today Healthcare Awards. The coveted award platform evaluates hospitals, companies and healthcare professionals on their outstanding performance in healthcare and life sciences sector. Also, for the first time in the country, the event will have specific conferences on Hospital Infrastructure and Planning with the theme of Challenges and solutions in hospital planning and the second conference will be on Medical Device & Technology with the theme of Connect, Engage and Explore.

Indian healthcare expenditure is amongst the lowest globally and there are significant challenges to be addressed both in terms of accessibility of healthcare service and quality of patient care. A significant portion of the Indian population is unable to access healthcare service because of inadequate healthcare infrastructure. Accessibility to healthcare infrastructure on an overall basis is relatively imbalanced and is 16 | January-February 2015 | Medical Device ASIA

extremely limited to rural areas of the country. The existing healthcare infrastructure is unplanned and is irregularly distributed. Further, there is a severe lack of trained doctors and nurses to service the needs of the large Indian populous. Healthcare infrastructure (majorly hospitals) requires necessary attention for India to revolutionize its medical and healthcare industry.

The event serves as a perfect platform to network with thousands of healthcare professionals along with generating business and increasing sales. The conference topics and Speaker sessions will provide valuable insights on new trends which could widen the customer base and help companies to stay ahead of competition. With participation from international companies and other countries, building relations to gain access to India and the sub-continent will be facilitated.

Some of the key associations supporting the event are Indian Association of Physical Medicine and Rehabilitation, Association of Healthcare Providers (India), ADMI - Association of Diagnostic Manufacturers of India, MSAHITA - Medical Surgery and Healthcare Industry Trade Association, Apollo Hospitals Group, Indian Association of Sports Medicine, Fortis Healthcare Limited along with other associations from the U.K, Germany, Korea.

“Medical Fair India would act as an enabler in bringing the entire medical fraternity on one platform where suppliers and buyers from different segments of the industry will congregate and do business. The 2-day

technical conference shall bring together eminent speakers from the medical fraternity who shall deliberate on vital issues being faced by healthcare industry professionals.” said Udo Schürtzmann, Managing Director, Messe Düsseldorf India Pvt. Ltd. He further said, “India has embarked on a of healthcare services transformation. The present Indian Government has introduced structural reforms and has re-emphasized its vision to create the access for improving healthcare services and to provide affordable healthcare for all.”

The private healthcare sector, in particular has witnessed unprecedented growth in the recent years and this holds immense business opportunities for companies interested to explore this huge potential.

India’s health challenges, though unique and complex, also offers remarkable opportunities. The coming years will witness major expansions & progress in the direction to consolidate the India healthcare sector.

About Medical Fair India The MEDICAL FAIR INDIA, held alternately in Mumbai and New Delhi every year, last time attracted 443 exhibitors and over 8,000 registered trade visitors across 3-day of the show to learn about the entire range of innovations from segments such as medical device technology, hospital, health centres and clinical equipment, rehabilitation, furnishings for pharmacies and care centres/furniture. The 21stMEDICAL FAIR INDIA will be held in Halls 11, 12 and 12A of the Pragati Maidan Exhibition Centre in New Delhi from 21 to 23 March 2015.

Amitabh Bachchan inaugurates latest technology in Eye Surgery · ·

The Vission Eye Center brings the latest ‘FemtoSecond Laser’ to Mumbai Amitabh Bachchan lauds the efforts by Dr. Himanshu Mehta

Mumbai gets its first ‘FemtoSecond Laser’ facility at The Vission Eye Centre, a leading eye care specialty clinic at Juhu, Mumbai. ‘FemtoSecond Laser’ is the latest platform in the world in the field of eye surgery and is a completely bladeless laser assisted eye surgery technology. The first-of-its-kind technology was inaugurated by superstar Amitabh Bachchan. Dr. Himanshu Mehta, a renowned eye surgeon at The Vission Eye Center has been instrumental in bringing this in Mumbai.

I

t is unquestionably the most technologically advanced option for the patients and offers numerous advantages over the previous versions.

The technology is capable of supporting Cataract and other procedures in a single platform.

It will enable eye surgeons to perform far more accurate, precise and controllable incisions when compared to the current standard procedures. For patients, ‘FemtoSecond Laser’ offers highest safety in procedures of eye surgeries.

While appreciating Dr. Mehta for bringing this technology to Mumbai, Amitabh Bachchan expressed the need to bring in the latest technologies to India.

He commented, “I am sure this technology will take the level of eye care to next level in and all kinds’ of eye surgeries especially cataract surgery can be successfully done in Mumbai.

He also added that Dr. Mehta is virtually a part of our family and he has operated upon Jaya.”

Amitabh Bachchan lauded

the efforts by The Vission Eye Center and Dr. Himanshu Mehta for bringing the very latest technologies into Mumbai in the last decade.

Dr. Himanshu Mehta, a senior doctor at The Vision Eye Centre, overwhelmingly acknowledged the technology and said, “The new technology will potentially enhance quality of surgeries and patient’s experience. We are extremely glad to bring this technology for our patients. It is indeed a new milestone in eye care treatment in Mumbai.”

As a leading eye surgeons of Mumbai, Dr. Himanshu Mehta has provided hope and clear vision to many of his patients.

He has performed over 10,000 eye surgeries during last 20 years. He is also proven to be an “eye surgeon of choice” to several bollywood celebrities and industry leaders.

FemtoSecond Laser is a revolutionary, robotic precision technology, certified by the

18 | January-February 2015 | Medical Device ASIA

US-FDA. The excellent performance enables to reduce dependency on human skill by replacing it with advanced technology. It enables surgeons to operate with unmatched precision and computercontrol, and customize the procedure to your eye. Thereby, ensuring predictable outcome in every single patient case.

About The Vission Eye Center The Vission Eye Centre is a synonymous in the eye care treatment. Known for its efficiency in last two decades, the Center, grown by leaps and bounds as a super speciality eye care center. The Vission Eye Center offers comprehensive advanced treatment in the Ophthalmology segment. The first Vission Eye Center was started in the year 1995 at Juhu by Dr. Himanshu Mehta who has received his super specialty training in Ophthalmology from Texas in United States. He also has over 10,000 eye surgeries to his credit. The Vission Eye Center team consists of specialist eye surgeons and ophthalmic doctors. The wealth of experience ensures that the Center stays at the forefront of state-of-the-art eye care in corrective eye surgery and innovation. The Vission Eye Center is also renowned for a high focus on patient care through world-class systems and procedures.

Recently, the Center has acquired Femtosecond laser technology. This technology is the latest in the eye care treatment. Femtosecond laser technology facilitates precise, incision free surgeries. This is particularly useful in critical cases of cataract and other eye related complications. The Vission Eye Centre also offers specialty services like Lasik Surgery, Conductive Keratoplasty, Cataract Surgery, Diabetic Retinopathy, Macular Degeneration, Retinal Detachment and Retinopathy etc. More details about Femtosecond laser technology are available on its website http://www.vissioneyes.com/ About FemtoSecond Lasers It is the latest technology in the field of ophthalmology. The role of FemtoSecond lasers in cataract surgery is to assist or replace several aspects of the manual cataract surgery. These include the creation of the initial surgical incisions in the cornea. The FemtoSecond laser technology has brought new levels of safest.

Femtosecond lasers are well suited for cataract surgery because of their ability to tightly focus energy to produce precise surgical incisions. This is a bladeless surgery and the patients do not require stitches.

Some of the benefits include • Robotic precision with Laser technology • Completely BLADELESS and painless • High precision & safety through Laser incisions • Upto 10 times more accurate than manual cataract surgery • US FDA Approved technology • Ensuring predictable outcome every time

Advancing Hospital Efficiency and Quality through Technology and LEAN Thinking Remember Hospital Efficiency and Quality Asia 2014?

IncorporatIng This years’ programme at a glance

A: Pre-Conference Day Conference Day 1 Conference Day 2 - Lean Focus Day 12 May 2015 13 May 2015 11 May 2015

12 - 13 May Prince Hotel and Residence | Kuala Lumpur, Malaysia Pre-conference Lean Focus Day: 11 May 2015 | In 2015, IQPC Presents Healthcare Week Asia and to bring you14the Post-conference Workshops Site Tour Maybest 2015 of Hospital Efficiency and Quality (HEQ) and Healthcare Informatics Featuring Speakers from Malaysia (HIT) case studies and technologies.

Plenary Focus: Improving Healthcare Delivery and Decongestion in Asian Hospitals through Leadership and Health, Technology

Lean Thinking to Create Engagement, Improve Safety and Optimize Healthcare Outcomes

Ministry of Singapore National Health Group and the Hong Kong Hospital Authority What’s the Story behind Healthcare Week Asia?

Your patients only receive as much care as your knowledge and Dr. Nor Akma bt Yusuf hospital infrastructure allow. In 2009, we started journeying with Deputy Director, Hospital Dr. Feisul Idzwan Mustapha Services Unit Asia’s hospital CIOs, CMIOs Public andHealth IT Physician, HeadsNonthroughManagement our inaugural Ministry Of Health Malaysia Communicable Disease Section, Dr. Cheung Wai-lun, Allen Healthcare Informatics (HIT) Conference.

DiseaseAsia Control Division Director (Cluster Services)

Ho Khai Leng Group CIO National Healthcare Group, Singapore

Ministry of Health, Malaysia

Hospital Authority, Hong Kong Come 2011, hospital CEOs, COOs and HODs told us they wanted to focus on process streamlining to decongest hospitals and resolve bottlenecks.

Stream B Focus: Decongesting Hospitals through Clustering, Process Streamlining and Step-Down Care

With their needs in mind, we created Hospital Efficiency and Quality (HEQ) Asia. This March, HEQ was at its best yet – We partnered with MOH Malaysia and brought 220 hospital leaders together.

Throughout the years, our HIT and HEQ events have been helping hospital leaders improve practices, learn from one another and adapt new technologies through success stories from the best (think Johns Hopkins, Siriraj, Tan Tock Seng, Apollo Group and Fortis.)

Now, our hospital leaders want the best of both worlds.

Therefore next May, we are proud to announce that these two enriching conferences will be thoughtfully blended together under Healthcare Week Asia 2015.

Featured top Hospitals Include:

You can look forward to two-days packed to the brim with the best of strategy and technology case studies from healthcare visionaries including these early confirmed STRATEGY and IT speakers: •

Professor David Ben-Tovim, Director of Redesigning Care and Clinical Epidemiology, Flinders Medical Centre, Australia Brought by: • toDr.you Cherdchai Nopmaneejumruslers, Assistant DeanSupporting in Qualitypartners: Development and Vice Hospital Director, Siriraj Hospital, Thailand • Dr. Arturo S. de la Peña, Senior Vice President for Medical Practice and Medical Director, St Luke’s Hospital (Global City), Philippines • Garry Semeniano, Head, Enterprise Quality, Changi General Hospital, Singapore • Dr. Khursiah, of Quality Unit and Clinicalenquiry@iqpc.com.sg Governance, Hospital Sultan Ismail, +65 6722Head 9388 Malaysia • Dr. Umapathy Panyala, Managing Director, Omni Healthcare Group, Indonesia • Michael Wong, CEO, Pantai Ayer Keroh, Malaysia • Dr. Sandhya Mujumdar, Deputy Director – Medical Affairs (Clinical Governance); Senior Specialist – Quality & Accreditation, National University NUH, Singapore • Dr. Tan Bee Hwai, Hospital Director, Likas Women’s and Children’s Hospital, Malaysia

Stream A Focus: Using Technologies to Drive Healthcare Delivery and Improve Physician and Patient Engagement

Plenary Focus: Aligning Appropriate Technologies with Key Strategies to Maximize Healthcare Outcomes Stream A Focus: Mobile Technologies to Achieve Golden Healthcare Standards: Case Studies from APAC Stream B Focus: Technological Advances and Requirements in Malaysia

Post-Conference Day - Workshops and Site Tour -14 May 2015 Workshop B: Integrating IT into Your Hospital’s Processes to Create Engagement and Quality Workshop C: Striking the Right Balance between Clinical and Commercial Demands within Your Hospital Site Tour D: to Gleneagles Hospital Kuala Lumpur

• • • •

A/Prof Edward Poon, Director Nursing Services, AMK Thye Hua Kwan Hospital, Singapore Datuk Dr. Zaininah Mohd Zain, Director, Hospital Kuala Lumpur, Malaysia Ho Khai Leng, Group CIO, National Healthcare Group, Singapore Dr. Hwang Hee, CIO, Seoul National Bandung University Bandung Hospital (SNUBH), Korea • Yuhan Shah, Head of IT, KPJ Ampang Puteri Specialist Hospital, Malaysia • J. Michael Henderson, MD, Chief Quality Officer, Quality and Patient Safety, Cleveland Clinic, USA • Dato Amir Firdaus Abdullah, Senior GM, Pantai Group Operations, Regional CEO, Gleneagles Hospitals and CEO Gleneagles Hospital, Malaysia Dsad • Daljit Singh, President, Fortis Healthcare, India • Arvind Sivaramakrishnan, CIO, Apollo Hospital Enterprise, India • Nestor Gomez-Montiel, Group Commercial Director, Siloam Hospital Group • Leon Jackson, CIO, U.M. Specialist Centre, Malaysia • Ashokkan Somuveerappan, CIO, Columbia Asia Hospitals, India www.healthcareweekasia.com • Dr. Cheung Wai-lun, Allen, Director (Cluster Services), Hospital Authority Hong Kong • Dr. Krit Pongpirul, Quality & Research Advisor, Bumrungrad International Hospital and Lecturer,Faculty of medicine, Chulalongkorn University • Dr. Tan Bee Hwai, Hospital Director, Likas Women and Children Hospital, Sabah Malaysia For more information, please visit: http://www.healthcareweekasia.com Medical Device ASIA | January-February 2015 | 19

ECL 105/412- the latest revolution in Coagulation Analyzers

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hrough thirty five years of its existence, Transasia Bio-Medicals Ltd. has led the Indian In-vitro Diagnostic Industry, in offering quality products and services. With an aim to provide innovations that aid in timely and accurate diagnosis, Transasia regularly introduces innovative and most advanced technology based on the requirements of the customers.

The last few years, have seen a rampant growth in the Indian -Shivdas Pokkalath, Product Managerpreventive and curative healthcare Coagulation, Transasia Bio-Medicals Ltd. industry. There are an estimated 50,000 clinical labs in cities, towns, district, villages and remote areas, which gives an indication of the huge patient base and the need to provide quality, dependable and timely diagnostic services.

Among others, the most common coagulation tests performed include PT, aPTT and D Dimer. The customer requirement is neatly classified into small, medium clinical labs and (component separation) blood banks. While in some labs, there is a need to perform PT, aPTT, fibrinogen and D Dimer, others such as blood banks routinely perform fibrinogen and Factor VIII. A set of customers specialized in coagulopathy, do perform certain rare parameters.

However, not all systems in the market are equipped to cater to these requirements. Additionally, not having small reagent pack sizes for D Dimer and unavailability of timely service in remote areas are issues that need immediate attention.

In a step towards resolution of critical issues mentioned above and cater to diverse but pertinent customer needs, Transasia recently launched two advanced coagulation analyzers, ECL 105 – Single Channel and ECL 412 – Four Channel. Both these analyzers use an innovative technology thereby giving most accurate/precise results at extremely affordable costs.

Key highlights/features of both the instruments include: Hardware

- Easy to operate LCD touch screen graphical display - Built-in incubator for cuvette - Facility for reagent incubation through magnetic stirring of

20 | January-February 2015 | Medical Device ASIA

reagents. Especially beneficial for mixing silica or latex based reagents as they require constant stirring to keep the particulate matter suspended in solution - Inbuilt robust thermal printer - Easy connectivity through USB ports, Ethernet ports and RFID detection facility - Storage of data and coagulation clotting curves is possible on an external drive - Test menu includes comprehensive range of tests from clotting to chromogenic* and immunologic tests(*only onECL 412) - Light scattering principle is used for performing the assaysClotting (640 nm), Chromogenic (405 nm) and D Dimer (800 nm)

Software

- Intuitive, user-friendly, with minimal simple logical inputs in programming tests, multi-standard calibration, plotting multilevel QC points and running tests - Proven technology of coagulation curve in percentage light scatter for clot detection

The ERBA ECL 105/ 412 performs the most comprehensive coagulation tests in semi-automated systems. The tests such as Fibrinogen, Factors assays, Lupus anticoagulant, Protein C , Protein S, AT III* and D Dimer are programmed and can be performed with minimum effort ( * only on ECL 412).

The QC plotting has been programmed keeping in mind the accreditation requirement of laboratory. Multilevel QC for each test is possible, a feature still rare in many single and four channel analyzers.

With all its advanced features, ERBA ECL 105/ 412 is equipped to perform complete range of hemostasis tests and give its end-users the freedom to choose the test of their choice. v

Your fingertips to diagnose your future illnesses through aura analysis GDV Bio Well camera from Russia now launched in India at Astroo World 2015

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n what it may seem like a science fiction but the revolutionary GDV camera claims that the aura images taken from this Kirlian technology can forecast the illnesses in body. The services are now available in Mumbai as Dr Jashvant Shah, an expert on the subject, has procured the technology from Russia. All that you need to do is to put the tips of your fingers under the camera. You get complete diagnosis report in less than 15 minutes.

The product and its usability will be demonstrated first at the Astroo World 2015 trade show at the Bombay Exhibition Centre in Goregaon from January 16 – 18 by Dr. J M Shah and his team. Dr. Shah has done joint case study with Dr. Konstantein Koroktov on heart patients at Pokrovskya Hospital. St. Petersburg Russia, under supervision of cardiologist Dr. Kukuyi. Informing about the GDV camera, Dr Shah said, “The GDV Camera complex consists of hardware and software, for the direct computer

registration and processing of a subject’s energy field. GDV pictures are created by a unique patented optical system and CCD camera in daylight conditions with real-time processing.

Diagnosis by Kirlian photography every six months can be useful for prevention of major diseases of brain, heart, kidney, lungs or intestines.”

The worldwide human genome project is for prediction of diseases. It is an international, collaborative research program whose goal is the complete mapping and understanding of all the Genes of Human beings.

Gene is one of the factors controlling heredity. This project will give healthcare providers immense new powers to treat, prevent and cure diseases.

Research in alternative medicine can help to prevent diseases at much lesser costs.

Dr. Konstantein Koroktov, Russian Scientist and Professor of Physics in St. Petersburg Technical University made this camera, computerised it and introduced in many scientific functions. In 1939 a Russian photographer Mr. Samuan Kirlian had invented this camera to take photograph of human aura. After his name this camera is known as Kirlian camera.

Ms Siraj Jondhale, organizer of Astroo World said, “The trade show provides a large platform to astrologers and their various studies and methods of forecasting. This year too there would be about 80 exhibitors from various parts of the country.

The exhibition brings in best of the Gurus from various streams like, Past Life Regression, Face Readers, Tarot Card Readers, Vastu-shastra consultants, Aura readers, Angel Card Readers, Alternative Medicines, etc.” v

Medical Device ASIA | January-February 2015 | 21

EKF highlighting heat and humidity compatible POC hemoglobin analyzer at Arab Health 2015 DiaSpect Tm – a robust hand-held analyzer delivering immediate hemoglobin results

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KF Diagnostics, the global diagnostics company, highlighted the robustness of its new DiaSpect Tm point of care (POC) hemoglobin analyzer at Arab Health 2015, held from 26-29th January in Dubai, UAE. The executives from EKF discussed visitors its new liquid-stable assay* for early sepsis detection, as well as previewing SensPoint, a new hand-held lactate analyzer with built-in connectivity functions to hospital or laboratory information systems.

Rapid hemoglobin results in all climatic conditions EKF’s new DiaSpect Tm lightweight, palm-sized hemoglobin analyzer is fast, easy to use and reliable for anemia diagnosis in all climatic conditions. By combining laboratory quality performance with unmatched measurement speed and extensive battery life of 40 days of continuous use, or 10,000 tests, this makes it an ideal POCT device.

DiaSpect Tm is already proving highly effective in challenging POCT conditions in many locations, including east Africa and south-east Asia. In such environments heat and humidity can affect the performance of a POC device and, more importantly, the cuvettes used for blood collection. Crucially, DiaSpect Tm is unaffected by these environmental factors due to its reagent-free disposable cuvettes, and the fact that it has no moving parts. DiaSpect Tm’s extremely long battery life, also ensures this handheld device is ideal for use outside of laboratories, or in resource poor locations.

22 | January-February 2015 | Medical Device ASIA

The plexiglass microcuvettes used

by DiaSpect Tm have a shelf life of 2.5 years and can be stored from 0 to 50°C, meaning that refrigeration is not necessary short term storage is possible at -30°C to 70°C for a maximum of 24 hours. Also making it ideal for POC use in all locations, DiaSpect Tm is factory calibrated against the HiCN reference method in accordance with ICSH and requires no re-calibration or maintenance, as it undertakes an automatic self-check between every measurement.

DiaSpect Tm is easy to use and requires minimal training as the user simply collects a capillary or venous blood sample of <10 µL in the microcuvette and inserts it directly into the analyzer.

Hemoglobin results, which be downloaded to a PC via USB or Bluetooth, are delivered in one second.

Early sepsis diagnosis The new CE marked Liquicolor® Procalcitonin liquid-stable assay* can be used on most automatic

chemistry analyzers as an early and specific indicator of sepsis.

Since Procalcitonin (PCT) levels elevate during systemic bacterial infection and sepsis, PCT can be used to quickly assess initial severity of sepsis.

The new Liquicolor® PCT immunoturbidimetric assay is precise, convenient and cost effective as it is available in a liquid-stable format, which can remain stable on-board a clinical chemistry analyzer for up to four weeks, and requires a minimal sample of just 20 µL. This assay can also improve laboratory workflow as it can be run on a primary chemistry analyzer and eliminate the need to split a sample. The reagent kit, calibrator and control sets are all available separately.

For more information on Procalcitonin, the DiaSpect Tm hemoglobin analyzer or EKF Diagnostics, please visit www. ekfdiagnostics.com. * The Liquicolor® Procalcitonin liquid-stable assay is unavailable for sale in USA, France, Germany, Austria, Spain, Italy and Japan

About EKF Diagnostics www.ekfdiagnostics.com

EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, Separation Technology Inc., DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases.

Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.

Welch Allyn Sharpens Focus on Women’s Health in Hospital Emergency Departments and Urgent Care Centers

Gold Nanoparticle Test Strip to Detect Heart Attacks

New KleenSpec® Single-Use LED Vaginal Specula offers greater convenience for providers and added comfort, safety for patients

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elch Allyn, Inc., a leading medical diagnostic device company that delivers pragmatic innovation at the point of care, has extended its family of Women’s Health solutions with the addition of the KleenSpec® Single Use LED Vaginal Specula. The new device, designed for hospital emergency departments, labor and delivery rooms and urgent care centers, features an integrated LED light source that provides enhanced visualization of the exam area by supplying uniform white light through the handle—safely sealed away from the patient. The single-use LED specula is designed to eliminate the time and expense of reprocessing metal specula and help reduce the risk of cross-contamination.

“The new KleenSpec® Single Use LED Vaginal Specula is the perfect addition to our family of Women’s Health solutions,” said Tracy Bennett, manager, Women’s Health and Lighting Products at Welch Allyn. “It provides the freedom of movement needed to perform pelvic exams quicker and more efficiently and comes ready-to-use right out of the package—physicians simply pull a switch to activate the device. With an on-time greater than 30 minutes and a five-year shelf life, it is a musthave for every hospital or urgent care facility that is interested in efficiency, patient safety and comfort.”  The single-use LED specula is made of smooth, molded acrylic that will not pinch or bind tissue, and the wide handles provide comfortable ergonomics, good balance, and are easy to manipulate during exams. It is available in a range of sizes for all types of patients, and is manufactured to deliver durability and reliability in a variety of hospital and urgent care settings.

Additionally, the integrated LED light source is powered by lithium-primary batteries that provide longer shelf life and withstands extreme temperature variations better than alkaline.

If the customer chooses, the batteries and LED light can be removed for disposal or recycling.

“By providing an integrated, single-use LED light source within our KleenSpec® Disposable Vaginal Specula our customers can perform comfortable exams without the hassle of locating, cleaning or reprocessing a light source,” added Bennett. “The integrated LED light provides a crisp, homogeneous spot and eliminates glare-back, projecting light forward—right where it is needed most. This device will literally enhance the way our customers see their patients.”

For more information please visit www.welchallyn.com.

24 | January-February 2015 | Medical Device ASIA

Increased levels of the protein troponin in a patient’s blood is a marker for a cardiac infarction that may have recently occurred. Researchers at NYU Polytechnic School of Engineering have reported in journal Plasma Processes and Polymers on the development of new test strips that use gold nanoparticles to detect troponin I (cTn-I) with high sensitivity, potentially leading to a fast and early test for heart attacks.

Unlike other gold nanoparticles, these are created using a microplasma chemical process that allows more antibodies to be stuck to the surface. The researchers were able to modulate the technique to be able to stick as high amount of them as possible, resulting in considerably greater ability to detect even low concentrations of cTn-I. From NYU: The microplasma-assisted synthesis of AuNPs has great potential for other biomedical and therapeutic applications such as tumor detection, cancer imaging, drug delivery, and treatment of degenerative diseases such as Alzheimer’s.

The routine use of gold nanoparticles in therapy and disease detection in patients is still years away: longer for therapeutic applications and shorter for biosensors.

The biggest hurdle to overcome is the fact that the synthesis of monodisperse, size-controlled gold nanoparticles, even using microplasmas, is still a costly, time-consuming, and labor-intensive process, which limits their use currently to small-scale clinical studies, Kurt H. Becker, a professor in the Department of Applied Physics and the Department of Mechanical and Aerospace Engineering, explained.

Welch Allyn Acquires HealthInterlink, LLC Assets

Telehealth solution enables remote patient vital signs monitoring to provide timely access to accurate data for chronic disease management enable providers to deliver high quality care, regardless of location.”

During a transition period, HealthInterlink’s current product will continue to be developed, sourced and sold

by HealthInterlink’s existing workforce. It will be business as usual for all HealthInterlink partners and customers while the integration and transition is underway.

Welch Allyn, Inc., a leading medical diagnostic device company that delivers pragmatic innovation at the point of care, today announced the acquisition of substantially all assets of Prairie Ventures telehealth company HealthInterlink, LLC of Omaha, NE. HealthInterlink is a medical software company and developer of a flexible, affordable, and scalable software-based remote patient vital signs monitoring solution that is 510(k) cleared for marketing in the U.S. HealthInterlink’s telehealth solution incorporates wireless patient monitoring devices and a mobile gateway device, (e.g., tablet or smartphone) that transmits vital signs data, answers to patient care plan questions, and patient messages to a HIPAA-compliant cloud-based web portal for patient data management by healthcare professionals and other authorized stakeholders.

According to Welch Allyn President and CEO, Stephen Meyer, the acquisition of the HealthInterlink assets offers Welch Allyn a unique opportunity to better serve its U.S. customers by offering them an mHealth solution optimized for cost-effective collection and delivery of remote health information.

“The acquisition of HealthInterlink’s assets is exciting news for Welch Allyn and is in keeping with our vision to help transform care wherever patients and healthcare professionals connect,” said Meyer. “As healthcare delivery becomes decentralized and extends beyond the traditional acute and ambulatory care locations where our offerings are used today, we intend to provide solutions that

“It is an exciting day for HealthInterlink,” said Danna Kehm, managing director of HealthInterlink. “For nearly 100 years Welch Allyn has been helping healthcare providers overcome complex challenges with simple solutions. As an innovative medical software company specializing in remote patient vital signs monitoring, we believe that joining Welch Allyn will accelerate adoption of a practical telehealth solution designed to provide better outcomes and value for patients and providers alike.

HealthInterlink’s software and telehealth expertise coupled with Welch Allyn’s sales, marketing, and customer support strength, will give clinicians a powerful tool to manage more patients outside traditional healthcare settings.”

According to a report published by the Centers for Disease Control and Prevention, chronic diseases and conditions—such as hypertension, heart disease, stroke, diabetes, chronic obstructive pulmonary disease

(COPD), and obesity—are among the most common, costly, and preventable of all health problems. Remote patient monitoring provides a solution for managing the increasing rise and cost of chronic disease.

According to a literature review published in Telemedicine and eHealth Journal, the preponderance of evidence from telehealth studies for congestive heart failure, COPD and stroke point to significant trends in reducing hospitalization and emergency department visits, preventing and/or limiting illness severity and episodes resulting in improved outcomes.

Welch Allyn’s first foray into remote patient vital signs monitoring enables timely access to accurate data for more efficient and effective chronic disease management. The company will have a particular focus on helping primary care physicians and cardiologists manage hypertensive patients.

“This acquisition will enable us to help clinicians prioritize patient care, allowing for early intervention and facilitating communication with patients outside traditional healthcare settings,” added Meyer.

“Furthermore, we believe that this represents an exciting opportunity to advance the trend of investing in non-hospitalized and post-acute care monitoring to help take cost out of the system and help patients adhere to treatment plans—in the doctor’s office and beyond.”.

Medical Device ASIA | January-February 2015 | 25

A More Effective Imaging Method for Prostate Cancer

by JOSHUA CHEN

Images from the planning software used for targeted biopsy. The tumor is drawn in blue on anatomic imaging overlaid with A) perfusion data and B) RSI-MRI data. The H&E stained histology after prostatectomy D) shows the true boundary of the tumor outline in blue. A 3-D rendering C) of the whole prostate (green) and the tumor (yellow) shows the spatial position of the tumor within the prostate. RSI-MRI identified a suspicious area which after biopsy and prostatectomy was proven to be high grade tumor. As shown, the tumor is barely visible in conventional imaging. Multimodal Imaging Laboratory, UC San Diego

Prostate cancer can spread beyond the prostate gland and become an extraprostatic extension (EPE). Currently, contrast enhanced magnetic resonance imaging (MRI) is used to detect and diagnose prostate cancer. This technique involves injecting patients with a contrast agent to identify where blood flows. This is important because cancerous tissues often undergo angiogenesis.

However, there is a problem in that tumors are sometimes indistinguishable from the surrounding healthy tissue and therefore avoid detection. Now researchers and doctors at UC San Diego and UCLA have developed a novel approach to imaging these tumors using diffusion MRI while getting rid of the distortions that come with the technique.

Diffusion MRI measures the diffusion of water in biological tissue. Tumors are denser than healthy tissue and thus restrict the flow of water. The downside to diffusion MRI is that it is susceptible to magnetic artifacts which are distortions in the MR image due to inhomogeneities in the field.

Water is an inhomogeneity because it is considered a diamagnetic substance. These distortions can place tumors as much as a half inch (1.2 centimeters) away from the actual location, which can be a major problem. To correct the error, the researchers developed a new imaging method called RSI-MRI, or restriction spectrum imagingMRI. This approach adjusts for the magnetic field distortions and measures the water diffusion in cancer cells. This technique can also predict tumor grade. In the study, RSI-MRI was able to successfully identify eight out of nine patients with EPE whereas the standard MRI used currently only identified two out of nine.

26 | January-February 2015 | Medical Device ASIA

RSI-MRI imaging showing biopsy proven high-grade cancer with extension into the right seminal vesicle (arrow). There is also a region of enhanced RSI signal in the right pubic bone showing a likely focus of metastatic cancer. The extension into the right seminal vesicle and likely metastatic bone disease has implications for subsequent treatment. Multimodal Imaging Laboratory, UC San Diego

Joshua Chen A student at University of California, Berkeley studying bioengineering, Josh Chen is an avid researcher passionate about 3D printing, stem cells, neuroscience, biomaterials, nanotechnology and so much more. He hopes to take aspects in engineering and combine it with medicine to improve the quality of lives of others by creating low cost solutions to solve large-scale medical problems in the future.

As Josh closely follows new therapies and technologies, he is inspired by the monumental work that scientists do each and every day. When Josh is not studying or working, he enjoys playing the cello, reading by the beach, or training as a competitive gymnast for Cal.

SIGNOSTICS GETS FDA 510K CLEARANCE FOR HANDHELD BLADDER SCANNER

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edical device company, Signostics, announced today it has clearance from the U.S. Food and Drug Administration to launch the SignosRT Bladder, the company’s new handheld bladder scanner.

“Signostics ultrasound systems are designed to enable physicians to improve clinical outcomes in hospital settings, rural and remote medical centres and in the office. The benefits of using ultrasound have been well known to clinicians for years, however only now have they had access to such a portable, affordable real-time ultrasound tool they can carry with them anywhere and everywhere.”

Stewart Bartlett Co-Founder and Chief Operating Officer

The SignosRT Bladder is an affordable, portable device designed to use ultrasound technology to automatically and non-invasively calculate bladder volume and has the potential to assist in reducing health care costs in hospitals and home-care support services.

The product is already sold in Australia and New Zealand with applications across a number of medical sectors including aged care, home nursing, midwifery, urology and palliative care. Plans are also underway to launch the device in Europe in March 2015.

Steve Wilson, Vice President of Business Development, said the SignosRT Bladder could help save money and get patients home sooner.

“Catheterization of patients with suspected urinary retention is a significant cause of urinary tract infections increasing the length of hospital stays,” he said.

“Research shows using ultrasound to accurately measure bladder volume before catheterization can reduce urinary tract infections by up to 50 per cent2, which is significant for both health providers and patients.”

Mr Wilson said the SignosRT Bladder addressed the

growing need for mobile medical devices that enabled better diagnosis and care at the bedside.

“This is a revolution in health care and has the potential to transform community nursing, geriatrics, in-hospital maternity care, and long-term care.

“We’re already getting a great response from the Royal District Nursing Service in Australia (RDNS SA) who use the scanners in home visits and we see a significant opportunity for the product where urinary tract infections are a problem in hospital or home settings, as well as in long-term care facilities.

“With a rapidly aging population in most Western countries, home health care is expanding and portability and affordability are key elements for adoption in this segment.

“The SignosRT bladder scanner weighs less than one pound and fits into the palm of your hand so it’s an easy tool for doctors and nurses to carry anywhere.” v

Medical Device ASIA | January-February 2015 | 27

EKF Molecular Diagnostics collaborates with ANGLE for liquid biopsy development using Parsortix and PointMan technologies Combined technologies may identify all mutations in gene sequences associated with clinical utility of targeted cancer therapies potential to identify all mutations in gene sequences associated with clinical utility of targeted cancer therapies. In contrast, competing genetic analysis systems generally amplify only those areas which may be predicted to be mutant and therefore may miss unexpected mutations.

EKF’s PointMan™ DNA enrichment technology

EKF Molecular Diagnostics has agreed a collaboration with specialist medtech company ANGLE plc, to investigate the combination of ANGLE’s Parsortix circulating tumour cell (CTC) harvesting platform with EKF Molecular’s PointMan™ DNA enrichment technology as a liquid biopsy. If successful, the resulting simple blood test could enable the investigation of unexpected ultra-low level mutations in a patient’s cancer for personalised cancer care.

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he collaboration will initially work on colorectal cancer and then expand to cover other cancer types. CTCs will be harvested from cancer patients’ blood using ANGLE’s Parsortix system and then analysed using PointMan™ DNA enrichment technology to identify genetic variation in the cancer.

Both EKF Molecular Diagnostics and ANGLE believe that the combination of the Parsortix system with PointMan™ technology may be advantageous for two reasons. Firstly, the PointMan™ system preferentially amplifies variant sequences of interest whilst suppressing amplification of the wild type i.e. normal DNA. As a result, it has the

28 | January-February 2015 | Medical Device ASIA

Secondly, PointMan is highly sensitive with the ability to work with very low levels of target material, potentially as low as one CTC. The high purity of the Parsortix harvest (low white blood cell contamination) and its epitope independence may enable the combined system to be widely deployed across different cancer types and stages of disease.

Cancer patient blood samples will in the first instance be processed under ANGLE’s existing research collaboration with the University of Surrey and the Royal Surrey County Hospital (Guildford, UK).

The University of Surrey Oncology Department has already processed 20 colorectal cancer patient samples with the Parsortix system and stored the harvested cells for analysis. This bank of samples is ready for analysis and should enable the collaboration to make rapid progress towards initial proof-of-principle.

If the collaboration is successful, EKF Molecular Diagnostics and ANGLE will explore ways to offer their respective systems as a combined solution addressing first the pharmaceutical drug trial and research use market and then,

as patient data are developed, the clinical market.

ANGLE’s patented Parsortix system can harvest rare CTCs in cancer patient blood – even when there is less than one CTC in one billion healthy cells. The resulting liquid biopsy (simple blood test), using technology such as PointMan, enables the investigation of mutations in the patient’s cancer for personalised cancer care. The Parsortix system is “open-source” and has been designed to work with all existing analytical procedures in the same way that the existing solid biopsy provides cancer cells for a wide variety of analytical procedures.

Andy Webb, CEO, EKF Molecular Diagnostics, commented: “Our PointMan™ DNA enrichment technology has demonstrable performance in the detection of ultra-low level mutations. The high purity of the CTCs harvested by ANGLE’s Parsortix system and the absence of immunomagnetic beads gives us confidence that it will be effective with the Parsortix harvested CTCs providing rapid molecular information to the oncologist.”

ANGLE’s Founder and Chief Executive, Andrew Newland, commented: “We are delighted to announce this collaboration with EKF. The combination of ANGLE’s Parsortix system with EKF’s PointMan™ system has the potential to provide a complete solution for the oncologist.

We look forward to an early proofof-principle.” v

Now CTCs Easy Analysis with the help of Nano Velcro Chip

Valedo Turns Video Games Into Smart Back Training Exercises

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number of technologies have been invented in recent years for capturing circulating tumor cells (CTCs) from whole blood. There are limitations to all of them, and one common problem is keeping the cells alive while removing them from the screening device. This is normally due to the same mechanism that grabs on to the circulating tumor cells and doesn’t let them go. A couple of years ago we wrote about the NanoVelcro microfluidic device that effectively harvests CTCs from blood, but it suffered from the same problem and required specialized equipment and laborious effort to remove the captured cells. Now the research team has developed a pretty simple release method so the cells can go under the microscope for analysis.

As the name implies, the NanoVelcro chip has a hairy array of nanoscale wires, each with antibodies of proteins found in CTCs at the tips. As the blood passes by the wire hairs, the CTCs stick to them. In the process of figuring out how to detach the cells, the team discovered that by lowering the temperature of the environment around the hairs from body temperature to 4° Celsius, the cells pop off and can be collected in pure, undamaged form. If everything goes as planned, we may see CTC capture devices being utilized in clinical practice for early screening and monitoring of cancer post treatment.

“With our new system, we can control the blood’s temperature — the way coffeehouses would with an espresso machine — to capture and then release the cancer cells in great purity, ” said Hsian-Rong Tseng, a professor of molecular and medical pharmacology at UCLA. “We combined the thermoresponsive system with downstream mutational analysis to successfully monitor the disease evolution of a lung cancer patient. This shows the translational value of our device in managing non– small-cell lung cancer with underlying mutations.”

30 | January-February 2015 | Medical Device ASIA

At CES, Hocoma, a Swiss firm, is showing off its Valedo lower back exercise and therapy device. It sticks to the back of the spine and continuously detects the posture of its user. While other similar devices are already in existence, the Valedo can be used as a fun training system when paired with compatible tablets.

It’s used as a sort of joystick to control video games on a tablet or TV screen, fooling the user into performing specific exercises while he’s thinking it’s all fun and games.

Fitness Watches: What You Need to Know Fitness wearables were a hot product at the 2015 International CES in Las Vegas. From cheap silicone Fitbit imitators to advanced bracelets with smartwatch capabilities, everyone seemed to want a piece of this increasingly saturated market. In the endless sea of CES fitness bracelets that visitors seen over four days, here are a few notable fitness watches.

Just in time for CES, Fitbit announced that their Charge HR and Surge trackers would finally start shipping.

While we made mention of Fitbit’s newest products last week, we were able to try them out on the show floor. We were especially intrigued by the Surge (the one on the right in the image), which features a touchscreen, heart rate sensor, GPS antenna, and more. All are contained in a water-resistant device that lasts seven days on a charge.

From afar, the InBody Band looked like just another fitness bracelet.

However, this tracker has a unique sensor on its face. Place two of your fingers on your opposite hand on the two silver electrodes, and the InBody Band quickly measures your body fat percentage. InBody as a company has been producing body composition scales used in clinics and homes for years, so we’re optimistic this will give a fairly accurate estimate of how much flab you have. The band will be available in March.

Magellan may be best known for their GPS receivers, but they showed us their recently announced Echo Fit Smart Sports Watch. Like many

fitness smartwatches, the Echo Fit has a display that can pair with your phone and show notifications and act as a remote. Magellan boasts that the Echo Fit has an industry-leading 8 month battery life on a single coin cell battery.

If you prefer weightlifting instead of cardio exercise, GymWatch is a wearable that tracks your reps. Strap it onto your arm or leg, fire up the app, and choose from a selection of over 900 exercises. Gymwatch will measure your range of motion and speed and tell you if you are performing an exercise improperly or at the wrong pace.

Withings may have gotten a few strange looks when it announced its pricey $450 Swiss-designed Activité tracker, but we think they might be onto something with a watch that has a classic design with high-tech innards. On display at CES was the new Activité Pop, a watch with similar analog faces, but with less expensive materials and a lower price of $150.

Finally, Misfit announced a partnership with glass crystal maker Swarovski to make its Shine fitness tracker even more attractive to wear.

The Swarovski Shine features a large crystal face that looks beautiful as a pendant or bracelet. Its upcoming purple crystal model hides a special feature: underneath the crystal is a solar cell, which means you’ll never need batteries or charging cables again.

Medical Device ASIA | January-February 2015 | 31

Enteromedics Clinches FDA Approval for Nerve Stimulator to Treat Obesity

Fight Wrinkles with iDerma Facial Beautification System

EnteroMedics, a company out of St. Paul, Minnesota, announced that its Maestro VBLOC vagal blocking therapy system can now be made available in the U.S. for people on the front lines of the war with obesity. The device intermittently blocks vagus nerve trunks by sending electronic pulses that interfere with natural signals coming from the stomach.

The system is indicated for patients with a body mass index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 coupled with additional condition such as hypertension or high cholesterol.

The patients must have also gone through a supervised weight management program within the past five years with little success.

The implantation can be done in an outpatient procedure and, since the native anatomy is not altered, it can be completely reversed and the device explanted as necessary.

Some details on what led to the approval: Approval of the Maestro Rechargeable System was based on the ReCharge Study, a randomized, double-blind, sham-controlled trial to evaluate the safety and effectiveness of the Maestro Rechargeable System in treating obesity. In an intention to treat (ITT) analysis of the study results, VBLOC-treated patients achieved 24.4% excess weight loss (EWL) at 12 months. At 18 months, VBLOC-treated patients maintained a 23.5% EWL. In a responder analysis of the ITT population at 12 months, over 50% of VBLOC-treated patients achieved 20% or greater EWL. The SAE (severe adverse event) rate, defined as the proportion of subjects in the VBLOC treated group who experienced an implant/ revision procedure, device or therapy-related SAE through 12 months post-implant, was 3.7% (n=6; 95% CI: 1.4% to 7.9%) in the ITT population. The most common ( > 10%) non-serious adverse events related to device, implant/revision procedure or therapy were pain at the neuroregulator site, and transient sensations of therapy such as heartburn/dyspepsia.

VBLOC Therapy is contraindicated for use in patients with cirrhosis of the liver, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging (MRI) or diathermy use is planned; patients at high risk for surgical complications; and patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators).

32 | January-February 2015 | Medical Device ASIA

Apira Science, makers of the iGrow, the only FDA approved lightpowered hair restoration system, will soon be releasing the iDerma Facial Beautification System that uses 142 red and infrared LEDs to help reduce wrinkles. There are already similar phototherapy systems on the market, but they are typically handheld or stationary, and so are inconvenient or donĂ­t provide much coverage.

Being a mask, the iDerma system can provide consistent coverage of the face and bathe it completely and at the same intensity and time length throughout. The system delivers 660nm and 940nm wavelength light, both with narrow and wide lenses in front of the LEDs to produce the even coverage. The mask is adjustable, so Dorian Gray and his whole family can use the same mask and look younger together.

The firm is currently signing up early users via Indiegogo and would like to follow up with as many people as possible to receive feedback and get an idea of how well the iDerma mask actually works.

Intact Medical Clinches New Optogenetics Used to FDA Clearance to Preserve Induce REM Sleep Breast Biopsy Specimens Intact Medical Corporation (Framingham, Mass) won FDA 510(k) clearance for its Intact excision system to be used to preserve removed breast tissue of up to 30mm in diameter.

Once the area is prepared, the wand is inserted through a 6mm-8mm incision and the tip expands to surround the tissue. A 10 second burst of radiofrequency energy is delivered through the tip ablating the tissue around the sample and freeing it for easy removal.

The sample maintains its architecture and is ready for standard histologic evaluation. The device comes with four different basket sizes that envelop around the sample, while the same wand is used with all four.

Dr. Pat Whitworth, Director, Nashville Breast Center, noted, “This new FDA clearance is highly significant, not just for Intact Medical, but more importantly, for womenís health professionals and patients, globally.

The expanded clearance recognizes the unique features and significant advantages of the Intact technology compared to core needle biopsy and open surgical excision procedures in certain situations. Specifically, for small breast lesions up to 30mm in diameter, the ability of the Intact system to remove and preserve the entire lesion architecture for assessment by the pathologist combines the minimally-invasive benefits of core biopsy with the diagnostic assurances of traditional surgical excisional biopsy. As someone who has performed more than 1,000 procedures with the Intact, I can attest to the advantages of this option for my patients.”

John Vacha, President and Chief Executive Officer of Intact Medical, noted, ìThis FDA clearance represents an important milestone for the company and is an acknowledgement of the unique capabilities of the Intact technology. With use of Intact, physicians can offer women the option of a fast and relatively simple procedure that can remove a lesion up to 30mm in diameter, while maintaining the lesion architecture for pathological analysis, versus capturing multiple samples of that tissue for analysis, which would not preserve architectural integrity. The impact of this new, expanded application of the Intact technology means that Intact could become a welcomed first-line alternative diagnostic procedure to open surgical excision, significantly reducing patient discomfort, recovery time, and costs.

Optogenetics, the ability to use light to activate specific neurons in the brain, is continuing to prove itself as an amazing new technique to study and hopefully control different diseases and conditions. In a first, researchers from MIT used optogenetics to induce REM sleep in laboratory mice, an ability that may answer a lot of questions about how sleep works and how it can be controlled and improved.

In a study published in Proceedings of the National Academy of Sciences, the team showed how cholinergic neurons, thought to be related to sleep, actually can be used to trigger REM sleep. The team used a wired head mounted light source that penetrated the skull to deliver light directly into the brain. The mice themselves were genetically altered so that their neurons produce a light sensitive protein derived from algae. When neurons expressing this protein are illuminated, they activate and turning off the light brings them back to their previous state. The researchers showed that triggering cholinergic neurons within the pedunculopontine tegmentum (PPT) and laterodorsal tegmentum (LDT) regions of the brain can induce more frequent REM states. Interestingly, the length of REM sleep periods did not increase and remained about the same as during natural sleep.

Medical Device ASIA magazine welcomes you at

“Medical Fair India”

21-23 March 2015 Pragati Maidan, New Delhi, India Medical Device ASIA | January-February 2015 | 33

TiaLinx AR60-A Contact-Free Breast Scanner Unveiled

BD Intelliport IV Medication Management System Cleared by FDA

TiaLinx, an Irvine, California firm, is releasing a new product for radiation-free and non-contact breast tissue screening.The AR60-A device emits non-ionizing electromagnetic radiation, focusing the beam using special wafer-thin panels and detecting the response using planar antennas.

The technology takes advantage of the fact that different cell types have different electrical properties. The AR60-A spots abnormal cell clusters and highlights them on the screen against a blue background of normal cells.

TiaLinx plans to apply for FDA approval for the device, with the goal of submitting the application by the fourth quarter of 2015.

Additionally, the product line will be spun-off into a separate new company called MamoMedix.

Tandem’s New t:flex Insulin Pump with Huge Reservoir Tandem Diabetes Care (San Diego, CA) just announced that the FDA has given clearance to its t:flex insulin pump. Having the largest insulin store of any system available, the t:flex is aimed at diabetics who consume greater quantities of insulin. The reservoir holds 480 units of insulin, which may be sufficient for even the most brittle Type 1 patients.

The device is based on the t:slim insulin pump, having the same design and interface, as well as the companyís MicroDelivery technology.

The company expects to begin shipments of the t:flex in the second quarter of 2015.

34 | January-February 2015 | Medical Device ASIA

BD Medical, a part of Becton, Dickinson and Company, announced receiving FDA clearance for its Intelliport Medication Management System. The product monitors manual IV bolus injections, automatically records how much of which medication a patient receives and warns of allergies by interfacing with the hospitalís electronic medical records.

The system comes with an IV site sensor, a wireless base, and a Windows-based touch-screen tablet. The base and sensor scan the barcode on the vial and measure the amount of medication that is injected. The base is non-sterile and reusable, while the sensor that goes inside of it is single-patient use. Thereís also a matching syringe labeler that sticks barcoded stickers to the luer tips of syringes to make everything work together.

BD is expecting that the product will be available in the spring of this year.

Next Generation Neural Implants Let Mice w

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hile we already know how to stimulate the brain and spinal cord to treat various neurological conditions, implants that actually work over long periods without damaging nearby tissue have been notoriously difficult to produce. Now scientists from Ecole Polytechnique FÈdÈrale de Lausanne (EPFL) and the Swiss National Centre of Competence

in Research (NCCR) Robotics have reported in journal Science on a new ultraflexible neural implant that can perform both electrical and chemical stimulation of neurons in dynamic environments.

The e-Dura device has multiple electronic tracks made out of cracked gold that can stretch and flex, and a microfluidic channel

Quanta SC+ Hemodialysis Cellular Backpacks Ferry System for In-Clinic or At-Home Drugs to Inflamed Tissues Treatment Cleared in EU Quanta Fluid Solutions (Alcester, England) won European regulatory approval for its SC+ hemodialysis system, a portable, cartridgebased system that can be used at the clinic or taken home. The company claims that this is the only hemodialysis system that can be used at home which matches the efficacy and flow rates (up to 500ml/minute) of traditional machines.

It’s a single pass device and relies on disposable cartridges that handle all the fluid management within their insides. Once a session is complete, the cartridge is simply disposed of and a fresh new one is used next time. Because the system is designed for both in-office and at-home use, patients can first become comfortable about the procedure with the help of a nurse and once ready can take the machine home for a more comfortable and private hemodialysis treatment.

Here’s the basics of using the SC+ system according to the product page: • Load the single-use disposable cartridge and connect to the dialyser, concentrates and blood lines.

• After automatic priming the system is ready for treatment.

• Disconnect by simply removing the disposables and the machine is immediately ready for the next treatment.

• No need for intensive disinfection or time-consuming cleaning between treatments.

ith Spinal Cord Injuries Walk AgainBit through which medications can be administered. The electrodes at the tips of the gold tracks are also flexible and are made of silicon/platinum microbeads. The researchers tested the new implants in the laboratory, demonstrating that they withstand millions of stretches, as well as being able to send electrical pulses and deliver chemical injections while under

stress. Moreover, the prototypes were implanted into mice with spinal cord injuries and were able to work effectively in restoring the animalsí ability to walk, performing extremely well for weeks at a time. This technology certainly brings new hope to those paralyzed due to spinal cord damage and to many others for whom practical neural implants would be a godsend. v

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nflammation is a common response to many underlying medical conditions, often hiding deep within the body and difficult to reach in a targeted way. Being able to deliver pharmaceutical cargo to inflamed sites can allow for imaging and treatment of the underlying conditions that cause inflammation in the first place. Researchers from University of California, Santa Barbara and Massachusetts Institute of Technology have developed a new technology that harnesses the bodyís immune system to deliver drugs and imaging agents to inflamed tissue.

The technique relies on inflammatory monocyte migration (monocytes are a type of white blood cells that hone in on inflammation), to carry tiny polymer particles dubbed ìCellular Backpacksî to their targets. The particles are attached to the monocytes with the help of an antibody that binds to their surface. These backpacks are too large for the monocytes to swallow whole, so instead they carry the load and perform their normal functions.

As the monocytes seek out inflammation, they bring their loads with them, able to penetrate endothelial monolayers and differentiate into macrophages as they would normally.

The researchers tested the technology on laboratory animals, finding that the backpack carrying monocytes gathered in significantly larger numbers around sites of inflammation than in the rest of the animal bodies.

Medical Device ASIA | January-February 2015 | 35

BBS Revolution Automatic Bladder Volume Measurement Device

Veta Smart EpiPen Case Helps Keep Patients Safe from Anaphylaxis

dBMEDx, a company with offices in Denver, Colorado and Bellevue, Washington, won FDA clearance to introduce its BBS Revolution automated bladder volume measurement device. It’s intended to help clinicians assess whether a patient really needs that catheter that is so often the source of urinary tract infections.

The ultrasound device requires only a squeeze of gel and a short sweep across the abdomen while pressing down the trigger on the handle. The system automatically calculates bladder volume and displays the reading on the screen. The whole process takes minutes to complete, doesnít require much training, and can be done by staff not trained in using ultrasound equipment. While the system is easy to use, the underlying technology is fairly complicated, producing a true 3D volume dataset using multiple b-mode slices that allows the measurement of the bladder.

Noninvasive Neural Stimulation Projects at Stanford A wide variety of medical conditions arise from either inactive or overactive neurons in the brain and other parts of the body.

Being able to control neurons to fire correctly may help treat many diseases and researchers at Stanford University are hard at work studying how transcranial magnetic stimulation (TMS) and ultrasound can make that happen.

TMS uses strong magnetic fields to stimulate regions of the brain, a technology that can use a good deal of research to narrow and focus the fields and to be able to activate regions deep within the brain. Ultrasound has relatively recently been shown to be able to perform similar tricks, the researchers using it to activate retinal nerve cells in an attempt to help correct vision problems. Hereís a Stanford video presenting some of the projects that are underway to help introduce noninvasive neural stimulation for new medical applications.

36 | January-February 2015 | Medical Device ASIA

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orgetting your wallet or purse at home is one thing, but if youíre severely allergic to a food, forgetting your EpiPen (epinephrine injection) can be life threatening. A new device will soon be available to help keep the EpiPen near and to automatically notify loved ones whenever itís used.

The Veta smart case has sensors built-in and communicates to a paired smartphone (iOS and Android) to make sure itís not left behind. Whenever the phone stops receiving a proximity signal, it sounds an alarm and lets you know the GPS location of the spot where it was last heard from. If a child is using it, it can also be made to let parents know that Tommy forgot to bring the EpiPen. To help find the exact spot of the Veta, you can activate its find-me feature whereby it will flash and sound a ringer. Thereís a temperature sensor built-in to make sure the epinephrine stays fresh. If you do end up using the EpiPen, the Veta case recognizes that itís been opened and immediately sends alerts, which include the GPS location of the user, to pre-selected people, like parents and school nurses. The device also goes through a safety confirmation routine, starting a countdown after the pen is activated. If the user doesnít respond to prompts from the app, it will eventually issue a loud notice to anyone around explaining the situation and calling for help. Interestingly, if you plan to be traveling aboard, the app can be setup to issue the warning in other languages.

Can ultrasound detect potential heart attacks, stroke before symptoms arise?

Study of portable ultrasound carried out in the USA, Canada and India has revealed the potential of this technology for detecting plaques in peripheral arteries that can lead to heart attacks and stroke before symptoms arise, in both developed and developing country settings, allowing preventive treatment in those affected. The study, published in Global Heart (the journal of the World Heart Federation), is by Dr Ram Bedi, Affiliate Assistant Professor, Department of Bioengineering, University of Washington, Seattle, WA, USA, and Professor Jagat Narula, Editor-in-Chief of Global Heart and Icahn School of Medicine at Mount Sinai, New York, USA, and colleagues.

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umerous research studies have shown that it is possible to assess subclinical atherosclerotic cardiovascular disease (ASCVD) using ultrasound imaging. Since more portable and lower cost ultrasound devices are now entering the market, along with increased automation and functionality, it may be possible in future to routinely examine people with ultrasound to establish any ASCVD present before symptoms emerge, so that future disease can be prevented, for example using medication. In this study, ASCVD was determined using ultrasound of both the carotid arteries (those in the neck) and the ileofemoral arteries (entering the top of the leg). The findings were conveniently Medical Device ASIA | January-February 2015 | 37

summarised in an easy to understand index called the Fuster-Narula (FUN) Score.

Data were gathered from 4 cohorts, 2 Indian and 2 North American. In India, a medical camp setting was used, and screening with automated ultrasound imaging was conducted over 8 days in 941 relatively young (mean age 44 years, 34% female) asymptomatic volunteers recruited from the semiurban town of Sirsa (Haryana) and urban city of Jaipur (Rajasthan) in northern India. The cohort from Sirsa was specifically recruited because all participants had already undergone aggressive lifestyle changes (smoking cessation, no alcohol, vegetarian diet, physically active lifestyles, daily meditation), Radiology resident doctors who had no prior training in vascular ultrasound were trained on the spot to perform the ultrasound examinations.

To compare the imaging findings with traditional risk factors, 2 cohorts (481 persons) were recruited from primary care clinics in North America (one in Richmond, Texas, USA, the other in Toronto, Canada).

As well as the same ultrasound examinations given in the Indian cohort, comprehensive ASCVD risk factor data was gathered from these participants, all of whom were self-referred asymptomatic individuals (mean age 60 years, 39% female). Data collected included cholesterol levels, blood pressure, glucose level, weight, height, smoking and family history. These people were attending clinics for routine health examinations in most cases. Effectiveness of established ASCVD prevention guidelines was then compared to results 38 | January-February 2015 | Medical Device ASIA

from direct imaging. Ultrasound was performed by trained experts at each centre.

In India, ultrasound revealed plaques in at least one artery in almost a quarter (24%) of those examined; 107 (11%) had plaques in only the carotids, 70 (7%) in both the carotids and iliofemoral arteries, and 47 (5%) had plaques in only the iliofemoral arteries. If just the carotids had been examined, 177 (19%) of the asymptomatic subjects would have been identified with plaques; by adding the iliofemoral examination, 47 additional individuals (5% of the total) were identified with plaque. Older age and male sex were associated with the presence of plaque both in urban and semiurban populations (the much higher levels of smoking in men could account for their higher risk).

Data from the American and Canadian clinics showed that 203 subjects (42%) had carotid plaque; 166 of these (82% of those with plaque) would not have qualified for lipid-lowering

therapy such as statins under the most widely used guidelines known as ATP III (Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults [Adult Treatment Panel]) guidelines. Using the recently published more stringent ATP IV guidelines, 67 people (one third of those with plaque and 14% of the total US/Canadian cohort) individuals with carotid plaque would also have failed to qualify for treatment.

In addition, the study revealed 34 people in the USA/Canada setting who qualified for treatment under ATP III but did not have any plaques, and this number increased to 81 under ATP IV (if receiving treatment such as statins, these people could be said to be overtreated, since no plaques were evident).

The authors say: â&#x20AC;&#x153;Our study shows that automation in ultrasound imaging technology allows even non-expert users to rapidly evaluate the presence of subclinical atherosclerosis

in a large population. Detection of subclinical atherosclerosis is further enhanced by inclusion of the iliofemoral artery examination.”

They add: “It seems that plaque information from ultrasound images may serve as a guide for initiating medical intervention regardless of the availability or knowledge of traditional risk factors.

Our results further suggest that not only in low- and middle-income countries, but even in the developed nations, ultrasound images may help refine strategies for medical intervention. It might however still be too contentious to suggest that risk factors-positive and imaging-negative asymptomatic subjects may be spared from medical intervention. Conversely, arguments against initiating medical intervention on risk factors-negative and imagingpositive asymptomatic subjects become harder to justify.”

In a linked comment published with this paper, Dr Tasneem Z Naqvi, Professor of Medicine at the Mayo College of Medicine and Division of Cardiology, Scottsdale, Arizona, USA, adds: “This study shows that the assessment of subclinical atherosclerosis by a portable, user-friendly bedside tool is feasible in large populations and the technique of carotid ultrasound imaging and IMT assessment could be adopted by novices after an 8-hour crash course.”

She concludes: “The study by Bedi et al puts into perspective the weakness of risk factor-based approach to identify individuals with subclinical atherosclerosis who are more likely to develop future cardiovascular events.

The study shows that the vascular ultrasound imaging technology is ripe and that the previously existing barriers such as poor resolution, cumbersome protocols, need for off line processing and need for expert performer no longer exist. The question that this study does not address?and perhaps no study in future might?is whether this imaging based approach would save more lives than the riskbased approach. We need to ponder if treating nearly 50% of the adults with statins with a risk scoring algorithm (as happens in the USA) is more appropriate versus treating only those who have subclinical atherosclerosis based on comprehensive and readily available, cheap and simple screening method.

This study makes a compelling argument in favour of imaging for screening.”

In an additional comment, Professor Paul Leeson, a member of the Imaging Enhancement Expert Working Group for

UK Biobank (with specific responsibility for the vascular imaging component), Professor of Cardiovascular Medicine at the University of Oxford and Clinical Director of the Oxford Cardiovascular Clinical Research Facility, UK, and not connected to the study or the journal, says: “Ultrasound seems to be firmly establishing itself as the advanced imaging technology of choice for global health care issues. Current ultrasound scanners generate accurate cardiovascular measures safely, rapidly and relatively inexpensively.

This paper nicely demonstrates how people with little imaging experience can undergo a short training programme and then use portable ultrasound systems in a wide variety of global health care settings. The fact this imaging technology can be applied to large populations has also made it an attractive option for many of the major biobank research projects, such as UK Biobank. These projects are planned to generate vascular images for hundreds of thousands of individuals in different countries that, over the next few years, can be used to determine the true value of vascular imaging for disease prediction.” v

Medical Device ASIA | January-February 2015 | 39

New technology to detect lingering cancer cells during breast surgery Any patients undergoing lumpectomy surgery at NYU Langone Medical Center for the removal of an early detected breast tumor -- the surgical option of choice for this diagnosis -- are benefitting from new intra-operative technology that detects microscopic amounts of cancer cells on removed tumor tissue not visible during or following surgical intervention.

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he Division of Breast Surgery at NYU Langone was the first in New York City to utilize MarginProbeÆ for early stage breast cancer. Manufactured and marketed by Dune Medical Devices, MarginProbe utilizes non-destructive radiofrequency spectroscopy technology in the operating room to analyze the outer margins of removed cancerous tissue to detect traces of cancer cells. If cancer cells are detected along the margins of the removed tissue, the surgeon excises additional tissue from the surgical site to ensure that no additional cancer cells remain.

“The greatest benefit of MarginProbe is that we can perform this additional tissue removal during a 40 | January-February 2015 | Medical Device ASIA

patient’s initial surgery, thereby sparing them the anxiety and frustration of additional followup surgery,” says Freya Schnabel, MD, Director of Breast Surgery at NYU Langone.

the likelihood that patients will leave the OR with a successful lumpectomy,” she says. “This technology is a real advance, and represents a further refinement of the lumpectomy procedure.”

MarginProbe was the subject of a major multi-institutional retrospective study led by Dr. Schnabel and published in the March 2014 edition in Annals of Surgical Oncology. The study examined close to 600 patients who underwent lumpectomies for non-palpable breast malignancies.

It concluded that the utilization of MarginProbe was as much as three times more effective in finding additional cancer on the margins of removed tumor tissue, compared to more traditional intra-operative imaging and other assessment tools.

Breast cancer is the most common type of cancer affecting women in the U.S., with over 285,000 new cases diagnosed each year. It is estimated that between 60 to 75 percent of these patients opt for a lumpectomy -- the removal of the cancerous lesion, but not the entire breast.

Most patients will undergo some form of post-surgical treatment, either chemotherapy or radiation therapy, or a combination of the two.

“We found that adjunctive use of the MarginProbe device in the operating room significantly improved surgeons’ ability to identify additional cancer cells on the margins of removed tumors,” Dr. Schnabel says. “MarginProbe’s detection of additional cancer cells along the margins of removed tissue indicates that additional tissue removal is warranted. This, in turn, improves the rate of a completely successful lumpectomy with no additional follow-up surgery required.”

Dr. Schnabel has used MarginProbe in more than 50 cases, and is extremely encouraged with the results. “The MarginProbe allows us to increase

MarginProbe’s greatest benefit is that it provides added assurance to both the surgeon and the patient that all cancer cells are removed during the initial surgery. “It is critically important to spare patients the additional burden of re-excision procedures and the time that is lost from work and family. MarginProbe helps us achieve that.”

An avocado a day may help keep bad cholesterol at bay Eating one avocado a day as part of a heart healthy, cholesterol-lowering moderate-fat diet can help improve bad cholesterol levels in overweight and obese individuals, according to new research published in the Journal of the American Heart Association.

Researchers evaluated the effect avocados had on traditional and novel cardiovascular risk factors

Researchers found: Compared to the baseline average American diet, low-density lipoprotein (LDL) -- the so called ‘bad cholesterol’ -- was 13.5 mg/ dL lower after consuming the moderate fat diet that included an avocado. LDL was also lower on the moderate fat diet without the avocado (8.3 mg/dL lower) and the lower fat diet (7.4 mg/dL lower), though the results were not as striking as the avocado diet.

Several additional blood measurements were also more favorable after the avocado diet versus the other two cholesterol-lowering diets as well: total cholesterol, triglycerides, small dense LDL, non-HDL cholesterol, and others.

by replacing saturated fatty acids from an average American diet with unsaturated fatty acids from avocados.

Forty-five healthy, overweight or obese patients between the ages of 21 and 70 were put on three different cholesterol-lowering diets. Participants consumed an average American diet (consisting of 34 percent of calories from fat, 51 percent carbohydrates, and 16 percent protein) for two weeks prior to starting one of the following cholesterol lowering diets: lower fat diet without avocado, moderate-fat diet without avocado, and moderate-fat diet with one avocado per day. The two moderate fat diets both provided 34 percent of calories as fat (17 percent of calories from monounsaturated fatty acids/MUFAs), whereas the lower fat diet provided 24 percent of calories as fat (11 percent from MUFAs). Each participant consumed each of the three test diet for five weeks. Participants were randomly sequenced through each of the three diets.

These measurements are all considered to be cardio-metabolic risk factors in ways that are independent of the heart-healthy fatty acid effects, said Penny M. Kris-Etherton, Ph.D., R.D., senior study author and Chair of the American Heart Association’s Nutrition Committee and Distinguished Professor of Nutrition at Pennsylvania State University, in University Park, Pennsylvania.

“This was a controlled feeding study, but that is not the realworld -- so it is a proof-ofconcept investigation. We need to focus on getting people to eat a heart-healthy diet that includes avocados and other nutrient-rich food sources of better fats,” KrisEtherton said.

“In the United States avocados are not a mainstream food yet, and they can be expensive, especially at certain times of the year. Also, most people do not really know how to incorporate them in their diet except for making guacamole.

But guacamole is typically eaten with corn chips, which are high in calories and sodium. Avocados, however, can also be eaten with salads, vegetables, sandwiches, lean protein foods (like chicken or fish) or even whole.”

For the study researchers used Hass avocados, the ones with bumpy green skin. In addition to MUFAs, avocados also provided other bioactive components that could have contributed to the findings such as fiber, phytosterols, and other compounds.

According to researchers, many heart-healthy diets recommend replacing saturated fatty acids with MUFAs or polyunsaturated fatty acids to reduce the risk of heart disease. This is because saturated fats can increase bad cholesterol levels and raise the risk of cardiovascular disease.

The Mediterranean diet, includes fruits, vegetables, whole grains, fatty fish, and foods rich in monounsaturated fatty acids-like extra-virgin olive oil and nuts. Like avocados, some research indicates that these not only contain better fats but also certain micronutrients and bioactive components that may play an important role in reducing risk of heart disease.

Medical Device ASIA | January-February 2015 | 41

Diagnostic screening: Microwave imaging of the breast may be better and safer

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lthough currently available diagnostic screening systems for breast cancer like X-ray computed tomography (CT) and mammography are effective at detecting early signs of tumors, they are far from perfect, subjecting patients to ionizing radiation and sometimes inflicting discomfort on women who are undergoing screening because of the compression of the breast that is required to produce diagnostically useful images.

A better, cheaper, and safer way to look for the telltale signs of breast cancer may be with microwaves, said Neil Epstein, a NSERC CREATE I3T postdoctoral fellow at the University of Calgary in Canada.

Epstein and his colleagues--engineering professor Paul Meaney of Dartmouth College’s Thayer School of Engineering and Keith Paulsen, director of the Dartmouth Advanced Imaging Center and the Robert A. Pritzker Professor of Biomedical Engineering and Professor of Radiology at the Geisel School of Medicine at Dartmouth College -- describe just such a microwave imaging system in the current issue of the journal Review of Scientific Instruments, from AIP Publishing.

Microwave imaging relies upon the known differences in the so-called dielectric properties of cancerous tissue and normal tissue--that is, their ability to conduct electricity or sustain an electric field. In the technique, the breast is suspended in a liquid bath (but not compressed) and closely surrounded by an array of 16 antennae. Each antenna illuminates the breast individually with a very low power microwave signal, with approximately one one-thousandth the power of a cell phone, while the other 15 antennae receive the signals transmitted through the breast; this is repeated for all 16 antennae, providing data that can be used to produce a 3-D representation of 42 | January-February 2015 | Medical Device ASIA

the breast, including the location of both normal and cancerous tissue.

“The iterative image reconstruction algorithm computes what the dielectric property distribution must have been to generate the measured signal patterns,” Epstein said.

“It is quite similar to X-ray computed tomography, where the target is radiated from all of the surrounding directions and the data is synthesized to create an image of the internal structures.”

Although microwave imaging systems cannot yet provide

the spatial resolution of mammography, they offer better specificity, Epstein said. In other words, once tumors are localized, the microwave imaging systems may be more adept at identifying whether those tumors are benign or malignant--determinations now made through tissue biopsies.

“Researchers are realizing that this lack of specificity is a significant limitation for conventional imaging techniques and are looking for alternative ways to enhance it. Microwave imaging could fill this niche, possibly in combination with other modalities,” he said.

Low-carb vegan diet may reduce heart disease risk, weight Researchers at St. Michael’s Hospital have shown for the first time that, in addition to weight loss, a specific low-carbohydrate diet may also reduce the risk of heart disease by 10 per cent over 10 years.

The diet, often called Eco-Atkins, is a low-carbohydrate vegan diet.

Many low-carbohydrate diets have been proven to improve weight loss but most emphasize eating animal proteins and fats, which may raise cholesterol. Diets that are high in vegetable proteins and oils may reduce the risk of heart disease by lowering “bad cholesterol.”

“We killed two birds with one stone -- or, rather, with one diet,” explained lead author Dr. David Jenkins, who is director of the Clinical Nutrition and Risk Modification Centre of St. Michael’s Hospital and a Nutritional Sciences professor at the University of Toronto. “We designed a diet that combined both vegan and low-carb elements to get the weight loss and cholesterol-lowering benefits of both.”

The findings, which were published in British Medical Journal Open, compared Eco-Atkins to a high-carbohydrate, low-fat diet. The EcoAtkins diet reduced cholesterol by 10 per cent while also helping participants lose an average of four more pounds than the highcarbohydrate, low-fat diet over six months.

“We could expect similar results in the real world because study participants selected their own diets and were able to adjust to their needs and preferences,” said Dr. Jenkins, who is a vegan.

Participants were given menu plans that outlined food items and amounts. Rather than requiring fixed meals, the menus served as a reference guide and participants were given a list of suitable food alternatives. With an exchange list of interchangeable food items, participants were better able to adapt the diet to their personal tastes -- which helped to encourage adherence to the diet.

Twenty-three obese men and women completed the six-month diet. Participants were encouraged to eat only 60 per cent of their estimated caloric requirements -- the amount of calories that should be consumed daily to maintain their current weight.

Eco-Atkins participants aimed for a balance of 26 per cent of calories from carbohydrates, 31 per cent from proteins and 43 per cent from fat -- coming primarily vegetable oils.

Carbohydrate sources included high-fibre foods such as oats and barley and low-starch vegetables such as okra and eggplant. Proteins came from gluten, soy, vegetables, nuts and cereals. Predominant fat sources for the Eco-Atkins diet were nuts, vegetable oils, soy products and avocado.

Bill introduced in Congress to simplify marketing of ‘research use only’ devices and diagnostics

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he Medical Testing Availability Act of 2015 would restrict the ability of the FDA to enforce tacit marketing of “research use only” diagnostics for clinical purposes.

The bill is sponsored by Rep. Michael Burgess (R-TX), who is also spearheading opposition on Capitol Hill to the FDA’s plans to regulate laboratory-developed tests.

The distinction between devices intended for clinical and research use is critical because the FDA’s regulatory authority is severely curtailed in the latter case. Devices for research or investigational purposes are generally not subject to PMA or 510(k) approval requirements. But the agency also determines which devices fall into which category, and can punish those who try and cheat the system.

A 2011 final guidance on the distribution of research use only (RUO) or investigational use only (IUO) diagnostic devices states the FDA can deem the devices adulterated or misbranded under federal law if it suspects they are being marketed for clinical use, even if their label clearly states the prescribed statement: “For Investigational Use Only.

The performance characteristics of this product have not been established.’’ t The newly introduced bill takes aim at FDA’s ability to take enforcement action in those circumstances. A bill with the same name was introduced by Burgess in 2013. But Republican initiatives now have a greater chance of passing since the party controls both chambers of

Congress.

Based on the previous bill, the legislation would alter current law to say that the FDA cannot declare a device or diagnostic misbranded if its manufacturer “sells the product to an end user who uses the product in a manner inconsistent with such statement (referring to the labeling)” or “engages in business communications regarding the product with an end user of the product,” such as “oral, written, or electronic contact between a manufacturer or distributor of such product and an end user regarding the functioning of such product.”

Business communications also include “technical support, customer service, assistance with the installation of such product, communication relating to ensuring the performance of the product, and other similar contacts.”

Devices for research use only have a surprisingly broad range.

According to the final guidance, in addition to diagnostic tests, the devices can include software, instrumentation and reagents, made by the likes of laboratory equipment companies such as Danaher ($DHR).

Philips’ ($PHG) line of digital pathology solutions, which digitize images of tissue samples seen under the microscope for further computer analysis, is also considered a research use only device. The company just announced that is adding advanced image analysis software made by Indica labs to its offerings.

Medical Device ASIA | January-February 2015 | 43

Medtronicâ&#x20AC;&#x2122;s IN.PACT Admiral Drug-Coated Balloon for PAD in Upper Leg FDA Approved in five patients (20.6%) treated with percutaneous transluminal angioplasty (PTA).

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edtronic-in. pactMedtronic received FDA approval for its IN.PACT Admiral drug-coated balloon for treatment of peripheral artery disease in the superficial femoral and popliteal arteries of the upper leg. As the balloon is inflated it emits paclitaxel, an antiproliferative medication, to prevent scar tissue from forming around the treatment site and blocking the artery anew. The device has been cleared in Europe since 2009 and has already been used in approximately 100,000 patients.

The IN.PACT Admiral has proven effective in maintaining patency of the arterial lumen after one year in a trial when compared with traditional percutaneous transluminal angioplasty. The reduced cases of restenosis will help prevent repeat procedures to re-open up the vessels and aid in maintaining a healthy lifestyle for those receiving the treatment.

44 | January-February 2015 | Medical Device ASIA

The data also revealed the highest reported rates of primary patency, which measures sustained restoration of adequate blood flow through the treated segment of the artery. Based on Kaplan-Meier survival estimates for primary patency at 360 days, the data showed an 89.8 percent sustained restoration of blood flow in the DCB group compared to 66.8 percent for the PTA group. Using the trialâ&#x20AC;&#x2122;s protocol definition, primary patency assessed at 12 months of follow up was 82.2 percent for the DCB group and 52.4 percent for the PTA group.

Some details on the clinical data that led to the approval according to Medtronic: The DCB arm of the IN.PACT SFA Trial demonstrated the lowest clinically-driven target lesion revascularization (CDTLR) rate ever reported for an interventional treatment of PAD in the superficial femoral artery (SFA), with only 2.4 percent of patients treated with the IN.PACT Admiral DCB requiring a repeat procedure at one year, compared to one

The exceptionally positive clinical data from the pivotal IN.PACT SFA Trial, which compared treatment with the IN.PACT Admiral DCB to standard balloon angioplasty, has been approved by the FDA without the use of an independent advisory panel.

The IN.PACT Admiral DCB is coated with a proprietary formulation of the drug paclitaxel and an excipient called urea, which facilitates the release of the drug when the balloon comes into contact with the artery wall.

Tattoo monitors glucose levels without needle

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anoengineers at the University of California, San Diego have tested a temporary tattoo that both extracts and measures the level of glucose in the fluid in between skin cells. This firstever example of the flexible, easy-to-wear device could be a promising step forward in noninvasive glucose testing for patients with diabetes.

Patch with printed electronics on an arm Nanoengineers at the University of California, San Diego have tested a temporary tattoo that both extracts and measures the level of glucose in the fluid in between skin cells. The device is flexible and easy to wear; ©UC San Diego/ Jacobs School of Engineering`

The sensor was developed and tested by graduate student Amay Bandodkar and colleagues in Prof.

Joseph Wang’s laboratory at the NanoEngineering Department and the Center for Wearable Sensors at the Jacobs School of Engineering at UC San Diego.

Bandodkar said this “proof-of-concept” tattoo could pave the way for the Center to explore other uses of the device, such as detecting other important metabolites in the body or delivering medicines through the skin.

At the moment, the tattoo does not provide the kind of numerical readout that a patient would need to monitor his or her own glucose. But this type of readout is being developed by electrical and computer engineering researchers in the Center for Wearable Sensors. “The readout instrument will also eventually have Bluetooth capabilities to send this information directly to the patient’s doctor in real-time or store data in the cloud,” said Bandodkar.

The research team is also working on ways to make the tattoo last longer while keeping its overall cost down, he noted. “Presently the tattoo sensor can easily survive for a day. These are extremely inexpensive - a few cents - and hence can be replaced without much financial burden on the patient.”

The Center “envisions using these glucose tattoo sensors to continuously monitor glucose levels of large populations as a function of their dietary habits,” Bandodkar said. Data from this wider population could help researchers learn more about the causes and potential prevention of diabetes, which affects hundreds of millions of people and is one of the leading causes of death and disability worldwide.

People with diabetes often must test their glucose levels multiple times per day, using devices that use a tiny needle to extract a small blood sample from a fingertip. Patients who avoid this testing because they find it unpleasant or difficult to perform are at a higher risk for poor health, so researchers have been searching for less invasive ways to monitor glucose.

In their report in the journal Analytical Chemistry, Wang and his co-workers describe their flexible device, which consists of carefully patterned electrodes printed on temporary tattoo paper. A very mild electrical current applied to the skin for 10 minutes forces sodium ions in the fluid between skin cells to migrate toward the tattoo’s electrodes. These ions carry glucose molecules that are also found in the fluid. A sensor built into the tattoo then measures the strength of the electrical charge produced by the glucose to determine a person’s overall glucose levels.

“The concentration of glucose extracted by the non-invasive tattoo device is almost hundred times lower than the corresponding level in the human blood,” Bandodkar explained. “Thus we had to develop a highly sensitive glucose sensor that could detect such low levels of glucose with high selectivity.”

Wang and colleagues applied the tattoo to seven men and women between the ages of 20 and 40 with no history of diabetes.

None of the volunteers reported feeling discomfort during the tattoo test, and only a few people reported feeling a mild tingling in the first 10 seconds of the test.

To test how well the tattoo picked up the spike in glucose levels after a meal, the volunteers ate a carb-rich meal of a sandwich and soda in the lab. The device performed just as well at detecting this glucose spike as a traditional finger-stick monitor.

The researchers say the device could be used to measure other important chemicals such as lactate, a metabolite analyzed in athletes to monitor their fitness. The tattoo might also someday be used to test how well a medication is working by monitoring certain protein products in the intercellular fluid, or to detect alcohol or illegal drug consumption.

Medical Device ASIA | January-February 2015 | 45

LASIK: A Fight FDA Can’t Ethically Win Dozens of patients claiming they were permanently injured by LASIK procedures have banded together on the Internet to exchange information and pressure FDA to take strong action against LASIK marketers.

The LASIK activists were joined in 2011 by Morris Waxler, the retired CDRH branch director who in 1999 led the reviews that approved excimer laser PMAs for the LASIK indication and who later recanted. From retirement, he petitioned the agency for their withdrawal based on his recalculation of adverse events that were more than 20 times greater than sponsors admitted in the PMAs.

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hat happens when an irresistible force meets an immovable object? Although logic says the two cannot exist at the same time, FDA may be about to find out, as it did in 1988, when persistent street demonstrators forced it to adopt emergency regulations slashing the review time for AIDS drugs.

This time, short of actual street demonstrations, the unreformed agency faces an equally persistent though numerically much smaller community of LASIK victims determined to force it to warn the public about an unacceptably high ratio of permanent injuries from the heavily promoted procedure.

As with the AIDS encounter 26 years ago, FDA still does not want to do what the activists want it to do.

It is bound by its sluggish institutional culture to not read the writing on the wall, partly because of the character of the people who wrote it and partly because of political discouragement from above.

46 | January-February 2015 | Medical Device ASIA

In the present case of laserassisted in situ keratomileusis (LASIK), dozens of patients claiming they were permanently injured by the procedure have banded together on the Internet to exchange information and pressure FDA to take strong action against LASIK marketers.

One of them, volatile Florida microjet broker Dean Kantis, apparently made himself so unpopular at CDRH by launching flamboyant allegations of criminality by named CDRH officials that he says his e-mails go unanswered and he has been insulted and hung-up on on the telephone by CDRH people.

Last year, after 30 months of stalling, FDA denied Waxlerís petition, saying it had not met ìstatutory standardsî (21 USC 515(e)(1) and 21 CFR 814.46(a)) and, anyway, the agency didnít believe LASIK was as dangerous as Waxler said. The denial cited published literature predominantly from LASIK practitionersí professioncontrolled publications that have refused to publish articles critical of LASIK. The activists, like their AIDS counterparts a quarter-century before, were not about to give up. In addition to forging a productive informal relationship with a knowledgeable non-FDA government expert who could help them, in December they took a new tack with a petition seeking an FDA black-box warning on LASIK laser labeling.

With millions of people having undergone laser eye surgery with such frequent problems,î the petitioners wrote, ìit follows that there is an epidemic of visual symptoms/night vision problems and dry eyes caused by

this unnecessary surgery. Unless the FDA immediately begins to provide adequately strong black-box warnings about the risks and adverse effects of laser eye surgery, the epidemic will continue to grow. There have already been several reports of LASIK-related suicide and countless reports of suicidal ideation. A black-box warning would help reduce the number of such negative outcomes and therefore falls well within the FDAís mandate of protecting and promoting public health.î Doubtless, this petition will meet the same fate Waxlerís did, probably sometime after the 2016 elections.

However, the activistsí new relationship with an FDA collaborator on LASIK at the National Eye Institute (NEI), Rick Ferris, has the outward appearance of providing them with the steel they need to turn FDA obstructionism around.

Ferris, it turns out, was on the FDA advisory committee that reviewed the first LASIK PMAs starting in 1998. He also represented NEI on the morethan-$1-million joint FDANEI-Department of Defense (DoD) LASIK Quality of Life Collaboration Project that last October reported preliminary results of two patient-satisfaction surveys among military and civilian personnel that were broadly positive for LASIK.

(Thatís the verbally cited cost LASIK activists say was given them by NEIís Rick Ferris. The U.S. Department of Defense said in an e-mail it didnít keep track of its costs in the project, Ferris declined to answer an e-mail on NEIís costs, and FDA said it had allocated $1.1 million to the overall project.)

All of this experience has apparently made Ferris unhappy with the way the LASIK indication was approved and subsequent eventsóalthough not as unhappy as Waxler. For example, the first lasers approved for LASIK, made by Summit Technology and VisX, were supported by safety data from only 75% of patients reached for follow-up at three months postoperation and only 63% at six months when the prevailing standard was 90% or better at 1 to 2 years postop, as recorded in the official transcript of the committee meeting.

According to extensive e-mails between Ferris and LASIK activist Michael Patterson, the NEI physician voted in the FDA advisory committee against the LASIK indication and is currently working to improve patient informed consent.

Patient informed consent is a key issue because LASIK activists say they were not given the FDArequired patient information booklet that is a condition of PMA approval (for LASIK

manufacturers, not for stateregulated LASIK ophthalmic surgeons). In 2006, CDRH quietly dropped LASIK PMA approval letter language requiring manufacturers to provide practitioners with the patient booklets.

Ferris expects to accomplish improved LASIK patient consent, according to his e-mails, through his participation in a final report with FDA and DoD counterparts on the joint-collaboration projectís two studies, to be published ìin the spring.î In one e-mail to Patterson, Ferris seemed to acknowledge that LASIK approvals had not been done properly, partly due to informed consent deficiencies: ìI canít fix the past but I am trying to get data for future consents.î That, it turns out, was the whole rationale for the joint LASIK Quality of Life Collaboration Projectónot to deliver a definitive assessment of real-world post-LASIK quality of life as advertised by FDA in its 2009 announcement, but to develop a scientifically sound survey instrument or questionnaire that could be used in the future to measure real-world post-LASIK quality of life.

The e-mails also revealed a significant activist disillusionment with CDRHís Office of the Ombudsman, which for years since director Les Weinstein retired has demonstrated no publicly visible positive results, and to which other offices routinely refer LASIK complainers.

Ferrisís admitted inability to ìfix the pastîóa past that he, Waxler, and current CDRH director of ophthalmic devices Malvina Eydelman all contributed toóhas been taken as a challenge by the LASIK activists.

In e-mail exchanges in January they were energized by the idea of pursuing the alleged wrongdoing they had uncovered in the clinical trials underpinning the original LASIK laser approvals, wrongdoing first uncovered by Waxler long after he had left FDA. They call it ìfraudîósomething that if shown should be sufficient to reverse the device approvals.

But, as FDAís petition denial letter to Waxler put in cold blackand-white, he hadnít met the ìstatutory standardî of proof (at least in FDA lawyersí eyes).

Even if he had, or even if the activists today can, the statute of limitations has run out. For this type of crime at the federal level, it is five years from the beginning of the criminal act.

While prosecuting original wrongdoers might be a blind alley now, the tirelessness of the activistsí other Internet-based effortsónow spanning nearly seven years of complaints and questions to FDAóparallel the ultimately successful efforts of AIDS activists during the Reagan Administration, when most people were unaware of the Internet.

Even if the original LASIK PMAsí now-discredited adverse events data were true (less than 1% incidence), that is the same incidence rate that AIDS has in the United States. Waxlerís recalculation places the actual LASIK rate at nearly 22%.

Add to the equation the fact that LASIK is a medically unnecessary procedure that leaves a permanent physical injuryóa U-shaped cut in the corneal surface that never healsóand you have a battle that, assuming the activists keep up the pressure, FDA is highly unlikely to win on ethical grounds. v

Medical Device ASIA | January-February 2015 | 47

Think Surgicalâ&#x20AC;&#x2122;s TSolution One Hip Replacement System

THINK Surgical (Fremont, CA) won FDA clearance for its TSolution One Surgical System for performing total hip arthroplasties. The system relies on pre-operative CT scans and consists of the TPLAN surgical planning application and the TCAT computer guided mill that prepares the bone cavity and joint surface.

The TPLAN software provides 3D tools to analyze and set parameters for milling the bones, helps in selecting the optimal implant, and helps define the best placement and alignment for the implant.

During the operation, the TCAT drill is used to prepare bone with sub-millimeter accuracy according to the developed plan. This way the system permits the creation of multiple plans, selecting an optimal course of action, all without expanding extra surgical time and hopefully leading to optimal results.

Hemopurifier FDA Approved to Filter Ebola Out of Blood in Clinical Study Aethlon Medical, a San Diego, CA firm, just announced that the FDA has given approval to a protocol for clinicians treating Ebola patients with the companyâ&#x20AC;&#x2122;s Hemopurifier device. Already successfully used in Germany to save a critically ill patient, the Hemopurifier filters out viruses and shed glycoproteins from blood in daily sessions lasting up to eight hours. In the German case, the physician treating the patient reported that the device captured 242 million individual Ebola viruses, with further analysis confirming the findings.

The FDA is allowing up to 20 potential patients to be treated in the study with the Hemopurifier, with up to 10 hospitals cleared to participate. The company is currently studying the device for treating Hepatitis C with patients on chronic dialysis, and the Ebola study is based on its protocol.

48 | January-February 2015 | Medical Device ASIA

Nanoplug Hearing Aid to Hide Within Ear Canal

Hearing aids have come a long way lately, thanks to new audio processing algorithms, miniaturization, and wireless capabilities. Yet, they can still be too large to wear inconspicuously and can get quite pricey. Now a new project raising money on Indiegogo aims to produce a hearing aid small enough to fit into the ear canal and cheap enough to sell for around $400.

The Nanoplug device is able to be this small thanks to its tiny battery, designed to be many times smaller than currently available hearing aid batteries. The team working on the device claims that it will hold enough charge to power the hearing aid for up to six days.

The device doesnâ&#x20AC;&#x2122;t completely fill the ear canal, allowing sound to be localized by the wearer, which is another common problem for hearing aids.

Portable Lens-Free Hollographic Sorin Memo 3D ReChord Mitral Valve Microscopy Brings Pathology Lab Annuloplasty Ring FDA Cleared Sorin Group received FDA Anywhere clearance for its Memo 3D ReChord annuloplasty ring designed for mitral valve repair procedures. The semirigid device is an upgrade to the existing Memo 3D ring, now featuring a new chordal guidance system that helps with implantation, particularly when performing artificial Gore-Tex chordae replacement.

The ring is covered with Sorin’s unique Carbofilm coating that, according to the company, improves the hemo-compatibility of the ring and its flexible shape, as the “3D” in the name implies, allows it to bend along with the heart’s motion while staying put within the annulus.

Tissue sample image created by a new lens-free microscope developed in the UCLA lab of Aydogan Ozcan.

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he lab of Dr. Aydogan Ozcan at UCLA seems like an everflowing wellspring of new optical gadgets that can be used in biomedical applications. Yesterday we reported on a new fluorescence imaging smartphone attachment developed by Ozcan et. al. that can be used to spot and measure DNA strands, and in the past we’ve covered other technologies the team developed to count cells, holographic processing to analyze them, and high-res 3D imaging of samples on a tiny chip.

Today we learn of a new study published by the researchers in Science Translational Medicine describing a new lens-free microscopy technique that allows for wide-field viewing of pathology slides using a small, cheap, and portable device. The device creates a holographically reconstructed image the objects within which can be brought into focus at any depth following the image capture. Unlike normal optical microscopes, this does not require any mechanical components to move the lens, making image capture nearly automatic.

From the study abstract in Science Translational Medicine: Using this lens-free on-chip microscope, we successfully imaged invasive carcinoma cells within human breast sections, Papanicolaou smears revealing a high-grade squamous intraepithelial lesion, and sickle cell anemia blood smears over a FOV of 20.5 mm2. The resulting wide-field lens-free images had sufficient image resolution and contrast for clinical evaluation, as demonstrated by a pathologist’s blinded diagnosis of breast cancer tissue samples, achieving an overall accuracy of ~99%. By providing high-resolution images of large-area pathology samples with 3D digital focus adjustment, lens-free on-chip microscopy can be useful in resource-limited and point-of-care settings.

Some more details about the Memo 3D ReChord according to its product page: •

The exclusive alloy core cell design is a laser-cut one-piece structure that allows truly physiological annular dynamics.

The precision laser-cutting technology is also used to obtain Sorin’s innovative Perceval sutureless aortic prosthesis.

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Ease of implant with superior visualization, placement and attachment while ensuring a perfect annular fit. The oval silicone sheath provides easy suturability with conformable needle penetration.

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Truly physiological three-dimensional motion of the mitral annulus with a natural anterior/posterior to lateral/lateral relationship to maximize blood flow, even after more than five years from implantation.

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The bio/hemocompatible properties of the unique CarbofilmTM coating allows complete endothelialization, prevents inflammatory reaction and scar tissue formation.

Designed to maintain physiological dynamics in the long term.

Medical Device ASIA magazine welcomes you at

“Medical Fair India”

21-23 March 2015 Pragati Maidan, New Delhi, India Medical Device ASIA | January-February 2015 | 49

How ‘Noisy’ Data Is Holding Hospitals Back tenfold every few years. In fact, in just two days, we create as much information as we did from the dawn of civilization to 2003.

Asha Saxena is the president and CEO of Future Technologies Inc., an international data management solutions firm.

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or many patients, all the information physicians collect before every appointment can be a big nuisance. Do physicians really need to know patients’ complete family medical history, drinking habits, and past surgeries for a consultation about seasonal allergies? Does all of this information actually help them make an accurate diagnosis?

Unfortunately, the answer is usually no. While it’s true that data is transforming the way doctors practice medicine, if left unstructured, data overload can become an enormous burden to healthcare organizations.

All of this noisy data just muddies the waters, making it more difficult for healthcare professionals to find what’s truly relevant — in other words, “smooth” data.

To avoid a full-blown data crisis, healthcare organizations must learn to determine what data is actually useful to physicians and take steps to restructure their data-analysis programs before the mountain of information overwhelms their facilities.

The Problem With Noisy Data Data overload is not a crisis specific to the medical field; it’s now an issue for nearly every industry.

Organizations collect data every time a consumer sends a text, makes a purchase on Amazon, creates a social media account, or views an article online.

It has been estimated that data is growing at a compound annual rate of 60 percent, increasing 50 | January-February 2015 | Medical Device ASIA

This data boom is both an opportunity and a curse.

Organizations are spending a lot of time and effort collecting as much data as possible, yet few organizations have perfected a system of refining that data into something clear and useful.

Sifting through mounds of irrelevant information can be an inconvenience in most industries, but in healthcare, it can be a liability.

If treating physicians are overwhelmed with patient information during an exam, it can hinder their ability to come up with a timely and accurate diagnosis. Likewise, organizations overrun with unstructured data can struggle with the cost of maintaining that data, managing staff, improving the quality of care, and advancing research and innovation.

For data to truly revolutionize healthcare, organizations must find a way to eliminate noisy data and transform it from its primary form into meaningful and intuitive information.

The True Value of Smooth Data With an infrastructure in place to turn unstructured data into actionable information, healthcare professionals will have the ability to: Predict illnesses before they occur by revealing correlations that might otherwise go unnoticed. For instance, by studying data from 30 heart

attack patients, researchers at the Intermountain Heart Institute in Salt Lake City identified markers that may help physicians predict when someone with heart disease is likely to have a heart attack.

Reveal new ways to treat illnesses quickly. The Chan Soon-Shiong Children’s Precision Medicine Institute at Phoenix Children’s Hospital is revolutionizing pediatric healthcare by applying genomic and proteomic analysis technology to translate diagnoses, treatments, and cures for pediatric patients more quickly and accurately.

Improve survival rates by catching illnesses early and allowing physicians to choose the best treatment possible.

Dr. Balazs Halmos of Columbia University Medical Center has given new hope to lung cancer patients by using molecular testing and specified patient information (such as genetic vulnerabilities) to generate the best combination of therapies for each individual patient.

Advance current and future medical research by identifying new or currently unknown connections between certain symptoms/traits and various medical conditions. By using precise data to guide his research, Halmos has been able to better understand how certain medicines affect the body and identify how some cancer cells resist certain drugs’ effectiveness.

The healthcare community has an opportunity and an obligation to refine data-driven medicine and build upon current practices until it’s usable at every hospital in the country. However, to get to that point, individual healthcare

organizations must take the steps necessary to create infrastructures that eliminate the noise from collected data.

How Hospitals Can Smooth out Their Data As it stands now, hospitals lack the proper infrastructure and visualization methods to ensure that physicians are seeing the most pertinent data.

Smoothing out data will boost the quality of care hospital-wide and improve patient outcomes.

To begin the process, hospital administrators must assess the current quality of their data and evaluate possible methods for refining the data-delivery process by: Determining organization strategies and goals.

Defining the hospital’s overarching goals will help guide administrators through the data-smoothing process. They should examine how those goals are being held back by noisy data and outline ways they’d like to improve procedures and care through data.

By making a list of far-reaching goals — like research programs or partnerships — administrators can gain a clearer understanding of what might be possible with a modified data system.

Evaluating data as it exists. Administrators need to take a close look at the data their hospital currently uses. Is there an infrastructure in place to sort out irrelevant patient information before it gets to the treating physician, or are doctors left sifting through decades’ worth of medical information as they try to make a diagnosis? Do data-management programs currently hinder or help the organization? Is there duplicate data that could be eliminated without compromising patient care?

Conferring with data users. Administrators should ask physicians how efficient the current data system is and if they have any complaints or suggestions for improving it. It’s crucial for decision makers to understand how doctors are utilizing patient data on a normal day. They may have some feedback and suggestions that can help streamline the system to be more user-friendly.

Assessing current metrics and performance. An indepth evaluation of the hospital’s overall performance and operations can uncover areas that are lagging because of inefficient data programs (or areas that are excelling thanks to smooth data). Administrators should evaluate metrics such as finances (e.g., physician/patient profitability and lags in posting charges), operations (e.g., discharges, length of stay,

and room charges), quality of care (e.g., mortality rates, readmission rates, and complications), staffing issues (e.g., payroll, overtime, turnover, and absences), and productivity to see how better data could help.

Exploring external infrastructures Other hospitals across the country can be a great source of information on how the organization’s data-refining procedures could be improved.

Have other hospitals experienced the same problems? Do any others have programs or refining processes that could be worth exploring?

Training staff on new procedures.

Whether administrators work with an internal team or an external company to smooth out hospital data, it’s important to devote adequate time and energy to training the entire staff on all systems and procedures. It won’t benefit the organization or improve patient care if the new program is slowed down because employees don’t know how to use it.

Re-evaluating annually. As technology continues to advance, it’s important for administrators

to frequently re-evaluate the efficiency of their datamanagement infrastructure.

They should go through the same process each year to ensure the program is still suitable for the organization and that the hospital has not outgrown its current data-refining process.

They may uncover new flaws in the system that need to be addressed or innovative ideas that could improve the current infrastructure.

The data boom in the healthcare field is now in full swing. The data hospitals collect has the potential to continually open new doors to innovation and advancement, yet few organizations have adopted data-refining programs that can support the glut of available information.

To truly benefit from the history patients provide, hospitals need a system to deliver actionable information to physicians in a timely manner. By establishing standards for data collection, analysis, and delivery, healthcare organizations can harness their data and use it to revolutionize the way they practice medicine and dramatically improve the quality of patient care.

DNA Detection and Measurement on a Smartphone Fluorescence microscopy relies on tagging biological samples using molecular markers that are excitable in response to light. The glow that emanates from the sample can be detected using specially designed microscopes, but these tend to be large and expensive. Now a small new device that works in tandem with a smartphone has been used to successfully spot and measure the length of DNA molecules using fluorescence microscopy.

According to the study of the device in ACS Nano, the scientists “imaged single DNA molecules of various lengths to demonstrate a sizing accuracy of <1 kilobase-pairs (kbp) for 10 kbp and longer DNA samples imaged over a field-of-view of ~2 mm2.”

Medical Device ASIA | January-February 2015 | 51

Magnets Finally Used to Guide Stethee Pretends to be a Nanoparticles Deep Within Body Cardiologist in Your Pocket

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agnetic nanoparticles have been researched extensively over the last few years as vectors for targeted delivery of drugs within the body. While the idea is full of promise, in practice using magnets to guide these particles to locations deep within the body has been difficult since magnets only pull one way and only areas close to the surface were subject to getting high enough concentrations of the nanoparticles. Now researchers from University of Maryland partnered with Weinberg Medical Physics, a Bethesda-based firm, to develop a technique that uses magnets to propel ferromagnetic particles within the interior of the body.

The system uses external magnets placed around the body and facing each other. Short magnetic pulses are used to create momentary magnetic fields that can influence the orientation and motion of the particles. They tested the technique using ferromagnetic nanorods and showed that the magnetic pulses can be used to orient the rods without actually tugging at them and to immediately push them toward the desired location before they snap back to their original spot. While the experiment was conducted in a laboratory, itís showing considerable promise for clinical applications and studies using animals are the next step in validating this technology.

The research partnership has led to the formation of Iron Focus Medical, a spin-off that plans to push the technology toward commercialization.

52 | January-February 2015 | Medical Device ASIA

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ardiologists will certainly scoff, but we have to report about the new Stethee automatic stethoscope the developers of which claim it will be able to warn you of cardiac conditions.

Itís still in prototype stage and the team behind the device are raising funds on Kickstarter to push it toward production, but the promise is that anyone will be able to hold the Stethee to their chest and get actionable results within seconds.

The device glows green when it thinks everything is honky-dory, while an orange glow implies that maybe you should get a professionalís look.

Interestingly, it also vibrates to the rhythm of the heart, letting you feel the heartbeat as youíre auscultating. Hereís a promo video for the device to help raise Kickstarter funds. Keep in mind the device is not an existing product quite yet, but is in final prototype stages.

RauSafe Needle Safety Device Upgrades Existing Primary Packs Cambridge Design Partnership (Cambridge, UK) together with Raumedic AG (Helmbrechts, Germany) developed a new needle safety device that helps prevent needle stick injuries by hiding the needle into sleeve following an injection. While there are similar devices out there, the new RauSafe product can be retrofitted to existing staked-needle prefilled glass syringes without having to revalidate drugs for safety in a new delivery device.

The device is being made available to manufacturers via licensing, allowing them to quickly adapt the system to existing primary packs without having to go through a complicated redesign and requiring only slight changes in the production process.

This should specifically help manufacturers supplying the European market where new rules are coming into effect that require syringes to have built-in safety systems that prevent accidental injuries.

NovaShield Injectable Nasal INTERCEPT Plasma Packing and Stent for Functional Transfusion Infection Control Endoscopic Sinus Surgery System FDA Approved

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edtronic just released its new NovaShield Injectable Nasal Packing and Stent for functional endoscopic sinus surgery (FESS). The product is made from chitosan, a polysaccharide derived from the shells of crustaceans, and is in the form of an injectable gel.

Following FESS surgery, it is placed in the sinus or nasal cavities to control infection, prevent bleeding, and keep things from sticking together, promoting optimal healing and hopefully improving long term outcomes. It breaks up and is easy to remove, unlike gauzes and sponges that are commonly used.

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erus Corporation out of Concord, California received FDA approval for its INTERCEPT Blood System for plasma, a product that’s used to prevent infections by treating blood plasma prior to a transfusion. The system relies on using a proprietary molecule to bind to the DNA and RNA of just about everything within the blood plasma sample. This molecule prevents the replication of nucleic acids, effectively deactivating viruses and bacteria that could be present.

The technique works because blood plasma, being empty of living cells, does not require DNA or RNA to be effective for transfusions. Because the system doesn’t target any specific pathogens but instead works on nearly all viruses and bacteria, there is no need for constant monitoring of relevant infections, having access to specialized assays, and having targeted compounds on hand to attack common pathogens.

It’s already being used for the current Ebola outbreak and to stockpile plasma gathered from patients that have recovered from the disease.

INTERCEPT pathogen reduction has been used in Europe for over 10 years as a safety option for platelet and plasma components, and more recently was made available in the U.S. under two Investigational Device Exemption (IDE) studies.

In the first study, INTERCEPT Blood System processed platelets will be used to reduce the risk of transfusiontransmitted dengue and chikungunya viruses, both of which are responsible for current epidemics in the Caribbean region, includingPuerto Rico, as well as cases reported in the Southern United States. In the second study, the INTERCEPT plasma system is being used to prepare Ebola convalescent plasma for passive immune transfusion therapy of acutely infected patients, providing an additional layer of safety against pathogens that these recovered donors may have been exposed to due recent travel in Africa. Plasma from recovered Ebola virus patients treated with the INTERCEPT process will be used to create a national stockpile for future patients.

Medical Device ASIA | January-February 2015 | 53

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