HospiMedica International May 2018

V I S I T

WORLD’S

CLINICAL NEWS

Vol.36 No.2 • 4-5/2018

LEADER DAILY CLINICAL NEWS

ISSN 0898-7270

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Multiparametric MRI Technique Could Replace Tumor Biopsies novel magnetic resonance imaging (MRI) technology can provide information about the nature and aggressiveness of a tumor without having to perform a biopsy.

Under development by researchers at the University of Texas (UT) Southwestern Medical Centre (Dallas, TX, USA; www.utsouthwestern. edu), the renal multiparametric MRI (mpMRI) algorithm is designed to recognize clear cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer, from MRI scans. The standardized diagnostic

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Gastric Bypass and Sleeve Gastrectomy Equally Effective new study concludes that in the morbidly obese, there is no significant difference in excess body mass index (BMI) loss between sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP).

Researchers at University Hospital Basel (Switzerland; www. unispital-basel.ch), St. Claraspital (Basel, Switzerland; www.claraspital. ch), and other institutions conducted a randomized, two-group trial between January 2007 and November 2011 involving 217 patients (average age 45.5 years, 72% women) who randomly assigned to sleeve gastrectomy

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Autologous Fat Harvester Facilitates Plastic Surgery

Advanced Monitor Tracks Brain Function During Anesthesia and Sedation

large-volume fat grafting solution offers plastic surgeons a convenient, closed system for harvesting and depositing autologous fat.

The MTF Biologics (Edison, NJ, USA; www.mtfbiologics.org) LipoGrafter is an efficient, selfcontained system for the atraumatic and low pressure, harvesting, processing, and grafting of human lipoaspirate. The system includes the K-VAC Syringe, which delivers constant, springactivated 300 mmHg harvesting

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ased on the bilateral acquisition and processing of four leads of electroencephalography (EEG) signals, the Next Generation SedLine brain function monitoring system helps clinicians control the effects of anesthesia on the brain during sedation procedures.

Image: Courtesy of Masimo

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Mobile Fluoroscopic System Continuously Images Extremities next-generation mini C-arm offers orthopedists, podiatrists and clinicians diversified imaging options, as well as upgraded storage and transport.

The Hologic (Marlborough, MA, USA; www. hologic.com) Fluoroscan InSight FD Mini C-Arm

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INSIDE Industry News . . . . . . . . . 25 International Calendar . . 26

News Update . . . . . . . . . . 6 Product News . . . . . . .6-10

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Point-of-Care Alert System Integrates With Electronic Medical Records novel point-of-care (POC) alert system links multiple data sources in order to assess care gaps, risk scores, disease registries, clinical documentation gaps, and other patient information.

The Innovaccer (San Francisco, CA, USA; www.innovaccer.com) InAssist POC alerts solution streams and integrates disparate data sources into a patient’s electronic medical record (EMR), recognizes when that patient needs attention, and offers actionable insights to healthcare providers; the data is presented on-screen via simple, real-time alerts

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News Update . . . . . . . . . 12 Product News . . . . . 12-14

News Update . . . . . . . . . 16 Product News . . . . . .16-20

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GLOBETECH >>> MEDIA <<<

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Multiparametric MRI Technique Could Replace Tumor Biopsies cont’d from cover

algorithm is largely based on the appearance of the renal mass on T2weighted MRI, and images taken immediately after an intravenous contrast agent is administered. Other images are also used to indicate whether fat is present in the tumor.

To examine the efficacy of the algorithm, the researchers retrospectively reviewed the records of 110 patients with 121 small renal masses who underwent MRI and partial or radical nephrectomy. Seven radiologists who were blinded to final pathology findings independently re-

New Guidance for Child X-Ray Exams he U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA; www.fda.gov) has issued a new guidance that recommends medical X-ray imaging exams in children and younger patients be optimized to use the lowest radiation dose needed.

In addition, the new guidance recommends that optimization of image quality and radiation dose in the X-ray imaging depend more on a patient’s size than their age, as smaller patients require less radiation to obtain a medically useful image. However, X-rays and computerized tomography (CT) scans should never be withheld from a child or adult who has a medical condition, if the exam may provide important healthcare information that may aid in the diagnosis or treatment of a serious or life-threatening illness.

The FDA guidance adds that healthcare professionals are responsible for ensuring there is justification for all X-ray imaging exams – including CT, fluoroscopy, dental, and conventional X-rays – performed on pediatric patients, and that they should also consider if a different type of imaging exam, which does not expose the patient to ionizing radiation, such as ultrasound or magnetic resonance imaging (MRI), could be used to obtain the same result.

“Technically, the patient’s body thickness, the distance an X-ray travels through the body to create the image, is the most important consideration when “child-sizing” an image protocol,” declared the FDA Center for Devices and Radiological Health (CDRH) in the new guidance. “Because children have longer expected lifetimes ahead of them for potential effects to appear, and the risk for cancer is not fully understood, it’s important to use the lowest radiation dose necessary to provide a diagnostic exam.”

Information is limited on cancer risks associated with diagnostic radiographic, CT, and fluoroscopically guided procedures during early childhood. Because of the dramatic increase in the numbers of children undergoing CT examinations internationally, it is particularly urgent to study occurrence of pediatric, adolescent, and adult cancer risks associated with these procedures.

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viewed the MRI images and applied a 5-level ccRCC likelihood score.

The results showed that scores of 4 or greater demonstrated 78% sensitivity and 80% specificity, while scores of 3 or greater showed 95% sensitivity and 58% specificity. The study was published in the October 2017 issue of The Journal of Urology.

“Using mpMRI, multiple types of images can be obtained from the renal mass and each one tells us something about the tissue,” said cosenior author Professor Ivan Pedrosa, MD, chief of MRI. “Based on the algorithm, doctors at UT Southwestern have a four-in-five chance of identifying clear cell cancer.” “Biopsies are not entirely free of pain and discomfort. Patients, in fact, choose to observe the cancer simply to avoid the pain of the biopsy,” said co-senior author professor of urology and radiology Jeffrey Cadeddu, MD. mpMRI refers to the multiple sequences required to make the diagnosis, consisting of both anatomic T1-weighted and T2-weighted MRI sequences, as well as functional sequences, such as diffusion-weighted imaging MRI and dynamic contrast-enhanced MRI. By combining different types of scans, a clearer picture of the scanned area becomes available. Injecting a contrast agent also helps to enhance the image.

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Advanced Monitor Tracks Brain Function During Anesthesia and Sedation next generation brain function monitor uses electroencephalography (EEG) to help clinicians better understand the effects of anesthesia on the brain.

The Masimo (Irvine, CA, USA; www. masimo.com) Next Generation SedLine brain function monitoring solution monitors the state of the brain under anesthesia via bilateral acquisition and processing of four leads of EEG signals. An enhanced signal-processing engine provides clinicians with a Patient State Index (PSi) parameter that relates to the effect of anesthetic agents. Next Generation SedLine also displays an enhanced, multitaper density spectral array (DSA), which represents activity in both sides of the brain and also transforms EEG data into the frequency domain.

A sub-algorithm detects subtle early Image: The Masimo Root and next-generation SedLine brain function monitor (Photo courtesy changes in EEG that signify decreasing of Masimo). sedation, and also scrutinizes changes in activity occurring between pairs of leads (PVi). RPVi is designed to provide enhanced to identify patterns signaling waning sedation noninvasive assessment of changes in fluid levels. In conjunction with the SedLine EEG volume and fluid responsiveness at a fraction sensor, Next Generation SedLine can be used of the cost of the top-end RD rainbow SET simultaneously with O3 regional oximetry on sensors, which can also measure total hemothe Masimo Root patient monitoring and conblogin (SpHb), carboxyhemoglobin (SpCO), nectivity platform for even more insight into a methemoglobin (SpMet), and arterial oxygen patient’s brain, by monitoring cerebral oxysaturation (SpO2). genation in situations in which pulse oximetry The RD rainbow Lite SET single-use sen(SpO2)alone may not be fully indicative of the sors are lightweight and have a flat, soft cable oxygen in the brain. with smooth edges, so that they lie comfort“Masimo is committed to innovation in the ably and unobtrusively on the patient’s hand brain function monitoring space,” said Joe or foot. The sensors also feature an intuitive Kiani, founder and CEO of Masimo. “With the sensor-to-cable connection, with both tactile improved performance offered by its enand audible feedback in order to ensure a hanced signal processing capabilities, we exproper connection, with additional graphics pect Next Generation SedLine to impact brain printed on both sides to assist with applicafunction monitoring, just as SET impacted tion. The RD rainbow Lite SET sensors have pulse oximetry.” received the European Community CE mark The Masimo Root connectivity and patient of approval. monitoring platform enables clinicians to “Rainbow Lite sensors allow clinicians, measure arterial BP using three distinct measwho depend on powerful SET pulse oximetry urement modes: spot-check, automatic intertechnology, to augment their patient monitorval, and stat interval, and also uses a module ing with ORi and newly introduced RPVi,” from Welch Allyn to measure temperature. said Joe Kiani, Founder and CEO of Masimo.

Other Root connectivity expansions are avail“We are excited to make ORi and RPVi accesable via Masimo Open Connect (MOC-9) softsible via the cost-effective solution represented ware, including CO2 capnography for sideby RD rainbow Lite SET. Hospitals that stanstream monitoring, O3 regional oximetry, redardize on RD rainbow Lite SET will pay only gional oxygen saturation (rSO2), and arterial nominally more per sensor than for SET.” oxygen saturation (SpO2).

Masimo SET is a noninvasive sensor technology that uses more than seven wavelengths Innovative Oxygen Sensors of light to acquire blood constituent data Assess Fluid Responsiveness based on light absorption. Advanced signal New disposable sensors monitor oxygen reprocessing algorithms and unique adaptive filserve index (ORi), a noninvasive and continuters work together to isolate, identify and ous parameter that provides insight into a paquantify various hemoglobin species, delivertient’s oxygen reserve in the moderate hypering blood measurement results in numerical oxic range. values. Basic Masimo SET measurements inThe Masimo RD rainbow Lite SET disposclude SpO2, PR, PI, and PVI, a measure of the able sensors utilize four wavelengths of light dynamic changes in perfusion index that octo measure both ORi and RPVi, a multi-wavecur during the respiratory cycle. length version of the Pleth variability index

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ISSN 0898-7270 Vol.36 No.2 • Published, under license, by Globetech Media LLC Copyright © 2018. All rights reserved. Reproduction in any form is forbidden without express permission.

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Point-of-Care Alert System Integrates With Electronic Medical Records cont’d from cover

within the EMR itself. In addition, InAssist synchronizes the EMR with the providers’ calendar and presents upcoming appointments via timely reminders. The application runs with all the browser-accessible EMRs, with no prior configuration needed.

The information can be customized to suit individual and specific needs, including relevant demographic details, time-sensitive care gaps, hospital coding gaps, diverse risk scores, specific patient markers (such as a frequent emergency department visitor), vital signs, lab results, medications, a list of recent visits, and a directory of the patients care team (principal physician, specialists, dietician, health coach, etc.). InAssist can also be integrated with other data systems using a proprietary application programming interface (API) that leverages Innovaccer’s InData platform to gain access to more information.

Autologous Fat Harvester Facilitates Plastic Surgery

“With the growing role of data and technology in healthcare, we understand the continued importance of providers spending more time with patients rather than spending half their day sorting through static files and millions of records,” said Abhinav Shashank, CEO of Innovaccer. “InAssist is a significant step in our commitment to making health data transparent, accessible, and impactful. We are optimistic that it will not only deliver crucial point-of-care alerts but also save a great deal of time for care teams.”

Recent studies reveal that physicians spend almost half their time on EMR and deskwork activities, and just over a quarter of their time with actual patients. Outside of office hours, physicians spent another one to two hours of

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Image: An innovative POC alert platform signals care needs within the EMR (Photo courtesy of Innovaccer).

PREMIER MULTIMEDIA PLATFORM SERVING THE WORLD’S HOSPITAL / MEDICAL COMMUNITY Anytime, Anywhere, On the Go...

PRINT MAGAZINE

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pressure; an atraumatic tissue valve (AT-Valve) for automatically transferring the lipoaspirate to the containment vessel without clogging; and tubing and bags for its collection, processing, and re-injection.

Following collection of the autologous fat, gravity sedimentation is used to concentrate it in collection bags by hanging them an IV pole, using sterile endotracheal tube stylet as hooks. The AT-Valve is then used to transfer the aspirate directly from the bag to the patient by switching it from harvesting mode to grafting mode, providing efficient micrografting of 0.1 ml /cm per pass, without switching between syringes and cannulas. Each sterile, single-use LipoGrafter disposable kit contains a KVAC syringe, four collection bags, the multi-port AT-Valve and a sterile tubing set with connectors.

“MTF Biologics is dedicated to offering surgeons innovative technologies and solutions that help them better serve their patients,” said Tom Shaffer, executive vice president of global sales and marketing at MTF Biologics. “As we continue to expand the many ways we work with and serve those in plastic and reconstructive surgery, we are proud to be able to deliver LipoGrafter, a revolutionary fat grafting system, to patients and plastic surgeons around the world.”

personal time each night on data entry demands. Another study, by the RAND Corporation (Pittsburgh, PA, USA; www.rand.org), confirms that EMRs and administrative obstacles that impede high-quality patient care are leading contributors to physician burnout.

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The OEG-17ADP functional NIRS equipment is the only device specifically developed to measure the head in its entirety utilizing fNIRS technology. Its lightweight and portability make it easy to mount and position the embedded sensors.

The Baby Shuttle offers the ideal microclimate for the premature baby. It is equipped with a smooth tilt bed positioning system, while its crushproof hood grants the maximum strength and thermal insulation.

The BeneVision N1 is designed for uninterrupted monitoring during intra and out-of-hospital patient transport. Weighing less than 1 kg, the palm-sized monitor provides clear viewing and streamlined workflow with intuitive operation.

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Radiofrequency Identification Tags Could Covertly Collect Vital Signs new study claims that microchip radiofrequency identification (RFID) tags could be used to gather blood pressure, heart rate, and respiration data.

Researchers at Cornell University (Cornell; Ithaca, NY, USA; www.cornell.edu) have developed small RFID tags that emit radio waves that bounce off the body and internal organs, and are then detected by an electronic reader that gathers the mechanical motion data from a location elsewhere in the room, using near-field coherent sensing (NCS). The RFID tags are powered by electromagnetic energy supplied by the central reader; since each tag has a unique ID code, up to 200 people can be monitored simultaneously using just one central reader.

According to the researchers, the approach has two possible implementations, using either passive or active RFID tags. Passive tags can be integrated into garments at the chest and wrist areas, with the two multiplexed far-field backscattering waveforms collected at the central reader to retrieve the heart rate, blood pressure, respiration rate and breathing effort of a single person. The researchers suggest that the passive approach can be used when minimal deployment and maintenance costs are required.

To maximize reading range and immunity to multipath interference caused by indoor occupant motion, active RFID tags could be placed in the front pocket and in the wrist cuff of the patients clothing in order to measure the antenna reflection due to NCS, with vital signals sampled and then transmitted entirely in digital format. As a result, the active system can monitor multiple people simultaneously, and could lead to the

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cost-effective automation of vital sign monitoring in care facilities. The study was published on November 27, 2017, in Nature Electronics.

In NCS, more electromagnetic energy is directed into the body tissue than with typical radiofrequency methods, where the energy is mostly reflected by the body surface, resulting in the backscattered signal from internal organs implicitly amplified by the multiplexed radio signals. At the same time, the shorter wavelength inside the body renders a small mechanical motion into a relatively large phase variation, which also increases sensitivity.

Image: This RFID tag could monitor multiple patients’ vital signs (Photo courtesy of Cornell University).

Monthly Brain Cycles Predict Epilepsy Seizures new study suggests it may soon be possible to know when epilepsy patients are at highest risk for seizures by identifying monthly cycles of brain activity.

Researchers at the University of California, San Francisco (UCSF; USA; www.ucsf.edu), the Wyss Center for Bio and Neuroengineering (Geneva, Switzerland; www.wysscenter.ch), and other institutions conducted a study in 37 subjects previously implanted with the NeuroPace (Mountain View, CA, USA; www.neuropace.com) RNS brain stimulation system in an attempt to define the relationship of seizure timing to fluctuating rates of interictal epileptiform activity (IEA), a marker of brain irritability observed between seizures by electroencephalography (EEG).

The study found that IEA oscillates with circadian and subject-specific multidien (multi-day) periods. The multidien periodicities, most commonly 20–30 days in duration, were found to be robust and relatively

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stable for up to 10 years in both men and women, and that the seizures occured preferentially during the rising phase of IEA rhythms. By combining the phase information from circadian and multidien IEA rhythms, a novel biomarker for determining relative seizure risk is available in most subjects. The study was published on January 8, 2017, in Nature Communications.

The NeuroPace RNS system is designed to detect the brain’s electrical activity. When it identifies seizure activity, it attempts to suppress the seizure by sending electrical stimulation through implanted leads to the brain. A physician-operated programmer communicates with the RNS, allowing stored information to be reviewed. An optional data transmitter can provide the physician with the information in real-time, so that the response to the stimulation can be evaluated to decide on the best seizure detection and stimulation settings for the patient.

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Wearable Biosensor Monitors Patients for Five Days wireless single patient, fully disposable vital signs biosensor provides convenience for caregivers and comfort for patients. The Vital Connect (Campbell, CA, USA; www.vitalconnect.com) VitalPatch is a state-of-the-art biosensor patch that monitors eight vital signs continuously, including heart rate, heart rate variability, respiratory rate, single-lead electrocardiogram (ECG), skin temperature, body posture, fall detection, and activity. The patch is powered by a disposable zinc air battery designed to hold up for 120 hours, in line with the U.S. national average of hospital patient length of stay of 4.5 days. VitalPatch can also be used beyond the hospital walls where continuous monitoring is needed, including post-discharge monitoring, remote patient monitoring, and in clinical trials.

Proprietary SensorFusion algorithms process thousands of data points per minute to produce accurate robust measurements, which are transmitted wirelessly via Wi-Fi to the VitalConnect Platform, which integrates the biosensor with mobile and cloud-based software and analytics so that patients can be monitored around the clock. Data analytics can help improve care for patients at risk, such as those suffering from sepsis, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and others. They can also help to detect early changes in patient physiology, potentially reducing mortality rates and days spent in the intensive care unit (ICU).

“We envision a hospital of the future where inpatient and outpatient care needs integrate more seamlessly to enable a patient-centric model of care that is truly preventative and real-time,” said Nersi Nazari, PhD, CEO and founder of VitalConnect. “The extended wear duration for our fully disposable VitalPatch biosensor supports our commitment toward improving patient care and enabling nurses and physicians to have realtime insight into their patients’ vitals and well-being.”

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Image: The VitalPatch biosensor patch, designed to monitor eight vital signs continuously (Photo courtesy of Vital Connect).

Novel Skin Patch Offers Solution to Antibiotic Resistance new study describes how a microarray patch that administers drugs directly into the bloodstream could provide an answer to the antibiotic resistance crisis.

Under development at Queen’s University Belfast (QUB; United Kingdom; www.qub.ac.uk), the unique antibiotic patch containing multiple 400 μm hydrogel-forming microneedle arrays that painlessly pierce the skin, turning into a gel-like material that consistently keeps the micropores open at an approximate 200 μm diameter. This provides a new avenue for delivering antibiotics directly into the bloodstream, thus bypassing the antibiotic-resistant gut bacteria and extending the lifespan of currently available antibiotics.

According to the researchers, oral administration of antibiotics contributes significantly to development of antibiotic resistance, since small quantities of the drug often finds its way into the colon, a perfect breeding ground for imminent drug-resistant bacteria. Injection of the antibiotic directly into the blood stream can significantly reduce the development of resistance amongst gut bacteria relative to oral administration, especially if the antibiotic is predominantly excreted through the kidneys. The study was published on December 2, 2017, in Journal of Controlled Release.

“For the first time, we’re in control of the rate at which medicine goes into the skin. We hope to show that this unique antibiotic patch prevents resistance development,” said study co-author professor of pharmaceutical technology Ryan Donnelly, PhD. Microneedles as a technique for drug delivery enhancement were primarily designed for facilitating percutaneous drug delivery. Since the emergence of solid microneedles two decades ago, which simply pierced the stratum corneum in order to enhance topical drug delivery, the technique has progressed in various modifications such as hollow, coated, dissolving, and hydrogel forming microneedles. In their turn, the modifications have resulted in new mechanisms of drug delivery enhancement, followed by an expansion of applicability range in terms of targeted tissues and organs.

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The Oxylog VE300 is straightforward, userfriendly and built to face challenges in preclinical emergency services. With reliable ventilation technology, robustness and intuitive operation, it provides reliable and safe assistance in an emergency.

The GRAPHNET advance features a 12-inch touch screen that displays waveforms and loops. It offers advanced modes such as PRVC, APRV, MMV+ Pressure Support, PSV+ assured Volume, along with dedicated neonatal ventilation modes.

The Eagle 2 series of disposable masks is meant to administer oxygen or other breathing gases for short-term or emergency applications. It has a membrane-sealed port for use during insertion of a bronchoscope or other endoscopic device.

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Electrical Impulse Device Improves Heart Failure Symptoms n innovative device delivers non-excitatory cardiac contractility modulation (CCM) signals to the heart muscle, initiating multiple biochemical and neurohormonal changes in the myocardium.

The Impulse Dynamics (Stuttgart, Germany; www.impulse-dynamics. com) Optimizer Smart implantable device is designed to deliver CCM signals during the absolute refractory period, just after the heart’s excitation. As a result, the contractility of the myocardium increases, with no concomitant increase in oxygen consumption, enabling the heart to operate more efficiently. Therapy is based on an implantable pulse generator (IPG) unit that senses the heart’s electrical activity and delivers CCM signals via two electrodes placed in the right ventricle.

The IPG unit is recharged on a weekly basis using a home-based charger system, without supervision, which assures it has enough energy to provide therapy for years, minimizing the need for battery replacement. The charger has a built-in display that provides instructions and feedback to the patient about the charging process. A portable programmer allows medical personnel to customize and optimize signal parameters according to individual patient needs, with dynamic evaluations made using the patient’s electrocardiogram (ECG) and marker channels. ”CCM technology meets a major need globally, and we are committed to demonstrating the value of CCM therapy to healthcare systems worldwide to benefit more patients with heart failure,” said Simos Kedikoglou, MD, CEO of Impulse Dynamics.

“CCM therapy is a new therapeutic method used internationally to treat patients with chronic cardiac insufficiency,” said Professor Christian Wolpert, MD, of Ludwigsberg Clinic (Germany; www.klinikum -ludwigsburg.de). “We have been applying this therapy to treat patients

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who have remained symptomatic despite a patient-specific medicinal regime at the Ludwigsburg Clinic for over four years now. Clinical studies have demonstrated that CCM positively enhances overall patient quality of life and physical exercise tolerance.”

CCM therapy is most suitable for patients with advanced heart failure (HF), a reduced ejection fraction (EF) higher than 20%, and normal QRS duration that cannot benefit from other device-based treatments, such as a cardiac resynchronization therapy (CRT) implantable device with pacemaker functionality.

Image: The Impulse Dynamics Optimizer Smart implantable device (Photo courtesy of Impulse Dynamics).

Sleep Training Device Helps Prevent Positional Obstructive Sleep Apnea n innovative sleep position trainer (SPT) prompts patients not to sleep on their back, thus helping to prevent Positional Obstructive Sleep Apnea (POSA).

The NightBalance (The Hague, The Netherlands; www.night balance.com) SPT is a small, lightweight device placed around the chest, inside a pocket in a neoprene strap which is be closed with a Velcro tab. Placed on the sternum, the device measures patient orientation using a three-dimensional (3D) digital accelerometer. The measurements are used to define the posture of the user: left side, right side, supine, prone, or upright. When in the supine position, the device emits a vibration stimulus, which provides feedback to the user.

The device continues to vibrate with a gradually increasing strength and stimulus duration, until a non-supine position is detect-

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ed. If the patient does not react to the stimulus, the vibrations are paused and then reinitiated after two minutes respite. The SPT is provided with an internal memory that stores sleep posture data for a period of at least 90 days. A USB port is used to communicate the data to a personal computer for analysis, and also to recharge the integrated battery.

In OSA, the muscles in the throat close in and block the airway during sleep. These gaps in breathing cause blood pressure to go up, because the oxygen level in the body falls and the brain sends signals to the blood vessels to contract so that oxygen flow to the heart and brain is increased. CPAP is the most commonly prescribed treatment for OSA, involving a mask worn during sleep that pumps air to help prevent the airway from closing.

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Critical Care

Biodegradable Sensor Helps Monitor Serious Health Conditions new study describes how a biodegradable pressure sensor can monitor chronic lung disease, brain swelling, and other medical conditions before dissolving harmlessly in the body.

Under development at the University of Connecticut (UConn; Storrs, USA; https://uconn.edu), the new sensor is made of two layers of piezoelectric poly-D,L-lactide (PDLLA) polymer film sandwiched between miniature molybdenum electrodes, and then encapsulated in layers of polylactic (PLA). The piezoelectric PLLA film emits a small electrical charge when pressure is applied to it, allowing it to precisely measure pressures between 0–18 kPa, and maintain reliable performance levels for a period of up to four days in an aqueous environment.

In a proof of concept study, the researchers implanted the PLLA piezoelectric sensor in the abdominal cavity of a mouse in order to monitor the pressure of diaphragmatic contraction and respiratory rate. The implanted sensor was hardwired to an external signal amplifier, which transmitted the enhanced electrical signals to an oscilloscope. After four days, the sensor broke down into its individual organic components. Immune response was confined to minor inflammation in the surrounding tissues, which returned to normal after four weeks. The study was published on January 16, 2018, in Proceedings of the National Academy of Sciences (PNAS).

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Cerebral Scanning Technology Detects Brain Pathologies portable, non-invasive device detects asymmetry of intracranial fluid volumes in patients undergoing neurological assessment.

The Cerebrotech (Pleasanton, CA, USA; www.cerebrotech medical.com) Visor is a novel bioimpedance spectroscopy device that detects changes and distribution of cerebral fluids using volumetric impedance phase-shift spectroscopy (VIPS). The device consists of a headband with multiple integrated antennas that broadcast and receive each other’s signals; the frequency response of the phase angle between a transmitter and receiver antenna represents changes in the electrical properties of tissue as a direct result of small changes in intracranial fluids.

A computer algorithm analyzes the changes in tissue electrical properties, providing a visual readout on a monitor of the detected changes.

The ratio of bioimpedance measurements between the brain’s right and left hemispheres, and especially changes in that ratio, can help detect any fluid asymmetry during neurologic assessment. Proprietary machine learning algorithms are then used to differentiate between the bioimpedance profiles of various brain pathologies, such as stroke, trauma, swelling, and others. The system has been approved by the U.S. Food and Drug Administration (FDA).

“We understand the challenges facing medical professionals who need to quickly assess patients with neurologic symptoms. The Cerebrotech Visor is designed to be portable, fast, and accurate,” said Mitch Levinson, CEO of Cerebrotech Medical Systems. “Utilizing the vast amount of data captured by our proprietary Cerebrotech Visor, our mission is to develop unique algorithms that can help physicians to better detect and diagnose a wide range of neurological conditions, improving outcomes for patients while reducing overall healthcare costs.”

“A simple, easy-to-use device that can provide accurate information about cerebral fluids in 30 seconds is an important development,” said neurologist Professor Andrei Alexandrov, MD, of the University of Tennessee Center for Health Science (Memphis, USA). “During neurologic assessment, presence and magnitude of fluid asymmetry is a critical piece of information that will help us understand and evaluate our patients. I see tremendous potential for this technology for a large crosssection of patients with neurologic symptoms and various conditions.”

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“We are very excited because this is the first time these biocompatible materials have been used in this way,” said senior author Thanh Duc Nguyen, PhD, of the UConn Institute of Materials Science. “Medical sensors are often implanted directly into soft tissues and organs. Taking them out can cause additional damage. We knew that if we could develop a sensor that didn’t require surgery to take it out, that would be really significant.”

“There are many applications for this sensor. Let’s say the sensor is implanted in the brain; we can use biodegradable wires and put the accompanying non-degradable electronics far away from the delicate brain tissue, such as under the skin behind the ear, similar to a cochlear implant,” concluded Dr. Nguyen. “Then it would just require a minor treatment to remove the electronics, without worrying about the sensor being in direct contact with soft brain tissue.”

Piezoelectricity, discovered in 1880 by French physicists Jacques and Pierre Curie, is a reversible effect in crystals that describes the internal generation of an electrical charge resulting from a mechanical force. For example, lead zirconate titanate crystals will generate measurable piezoelectricity when their static structure is deformed by about 0.1% of the original dimension. Conversely, those same crystals will change about 0.1% of their static dimension when an external electric field is applied to the material. The inverse piezoelectric effect is used in the production of ultrasonic sound waves.

Image: A biodegradable piezoelectric pressure sensor can monitor a wide range of medical conditions before dissolving safely (Photo courtesy of Thanh Duc Nguyen /UConn).

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WIRELESS EEG

VITAL SIGNS MONITOR

Air Liquide Medical Systems

Nihon Kohden

Arjo Huntleigh

The Orion-G features a 7-inch TFT color touch screen that can display up to four curves, along with a trend analysis of 15 patient parameters for 72 hours. Its highly responsive encoder knob helps users to choose and set the parameters.

The Aireeg WEE-1200 delivers real-time EEG waveform access and sampling frequency up to 4,000 Hz per channel. It is designed for easy access to RT data during epilepsy monitoring, intensive care and routine EEG environments.

The SC300 offers measurements such as NIV blood pressure, pulse rate, pulse oximetry and a wireless tympanic temp option.

Equipped with a 12-hour battery pack, it can be used in any healthcare setting and is suitable for all patients.

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Deep Brain Stimulation Improves Survival in Parkinson's Patients new study suggests that deep brain stimulation (DBS) could extend the life of people with Parkinson’s disease (PD). Researchers at Hines Veterans Affairs Hospital (HVAH; IL, USA; www.hines.va.gov), Northwestern University (NU; Chicago, IL, USA; www.northwestern.edu), and other institutions conducted a retrospective analysis of HVAH and Medicare administrative data of 611 veterans (mean age 69 years) with PD who received a surgical DBS implant between 2007 and 2013. Participants were matched to a similar cohort of 611 veterans with PD that did not receive DBS. The main outcomes were overall survival rates.

The researchers paired each DBS patient with a clinically and demographically similar non-DBS patient – for example, in terms of age and symptom severity – and tracked survival from the date when surgery either took place for the DBS group; or might have theoretically taken place, for the non-DBS group. The results showed that patients treated with DBS survived an average of 6.3 years after the surgery, versus 5.7 years for the non-DBS patients, a difference of eight months. The study was published on November 18, 2017, in Movement Disorders.

“There is an immediate effect on patients who have DBS on their motor function – the dyskinesia [involuntary muscle movements] is either gone or greatly reduced. The patient can move around and do things they hadn’t been able to,” said lead author Frances Weaver, MD, of HVAH. “The surgery may get patients back to where they were when the medication was effective. That is, DBS is typically as effective as the medication, if the medication was still working.”

DBS is a surgical treatment involving the implantation of a medical device called a brain pacemaker, which sends electrical impulses to spe-

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cific parts of the brain. DBS in select brain regions has provided remarkable therapeutic benefits for otherwise treatment-resistant movement and affective disorders such as chronic pain, Parkinson’s disease, tremor, and dystonia. DBS directly changes brain activity in a controlled manner, its effects are reversible (unlike lesioning techniques), and it is one of only a few neurosurgical methods that allow blinded studies.

Image: New research suggests deep brain stimulation can extend the life of Parkinson’s patients (Photo courtesy of Getty Images).

Hyperbaric Oxygen Ameliorates Alzheimer’s new study reveals that hyperbaric oxygen treatment (HBOT) may alleviate symptoms experienced by patients with Alzheimer’s disease (AD). Researchers at Tel Aviv University (TAU; Israel; www.tau.ac.il) and Assaf Harofeh Medical Center (Tel Aviv, Israel; www.assafh.org) conducted a mouse model study of AD that exposed old triple-transgenic (3xTg) and non-transgenic mice (controls) to HBOT in a custom-made hyperbaric chamber suitable for small animals. The mice then underwent HBOT for one hour per day for a period of 14 days, following which they underwent a series of behavioral, histological, and biochemical analyses to examine how the pathological hallmarks associated with AD were affected by HBOT. The results showed that HBOT reduced behavioral deficiencies in 3xTg mice, reduced plaque pathology by 40%, and reduced neuroinflammatory processes by reducing astrogliosis, microgliosis, and secre-

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tion of proi-nflammatory cytokines, while increasing expression of antiinflammatory cytokines. HBOT also reduced hypoxia, amyloid burden, and tau phosphorylation in the 3xTg mice. The researchers are now testing the effectiveness of HBOT on an additional mouse model of AD to investigate the mechanisms underlying its impact on the disease. The study was published on October 20, 2017, in Neurobiology of Aging.

HBOT involves 100% pure oxygen delivered to a patient at atmospheric pressure three times higher than normal air pressure in an enclosed chamber. At those pressures, the body is able to incorporate more oxygen into blood cells, blood plasma, cerebral-spinal, and other bodily fluids; the increased oxygen absorption significantly enhances the body’s ability to aid in its own healing. In 1937 hyperbaric oxygen treatments were first used for decompression sickness, but it was not until 1956 that HBOT was used as a therapeutic aid in cardiopulmonary surgery.

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Critical Care

Portable Video Laryngoscope Facilitates Intubation new video laryngoscope boasts a larger, brighter, higher resolution display that helps users obtain a better view of the airway.

The Dilon Technologies (Newport News, VA, USA; www. dilon.com) CoPilot VL+ video laryngoscope is an advanced airway management device developed to help providers have the optimum view of the airway when placing breathing tubes. Features include a large 4.3”, high resolution, sunlight-breadable display, a high resolution camera with brighter light emitting diodes (LEDs), the ability to record video to a micro SD card, and a new and improved Bougie port that enables direction of the endotracheal tube through the vocal cords.

Instead of requiring a clinician to lift, move, and straighten a patient’s airway anatomy, the angulated blade of the CoPilot VL+ respects the natural curve of the oropharynx; a standard bougie can then be delivered directly to where the camera is looking. The system also includes disposable bougies and disposable sheaths with an anti-fog coating and a smaller footprint, which allows for more room to manipulate the endotracheal tube. A rigid stylet for intubation without a bougie is also available.

“Our patented bougie port remains an integral feature of our disposable sheath. The bougie port gives our users an additional option for intubation, and makes it easier to get the tube ‘around the corner’,” said

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Pjerin Luli, director of sales and marketing at Dilon Technologies.

“Dilon Technologies also offers disposable bougies and a rigid intubation stylet that are compatible with any laryngoscope.”

Video laryngoscopy provides several advantages over direct intubation with Macintosh or Miller blade laryngoscopes. These include improved visualization, as the eye and airway need not be lined up as in direct laryngoscopy; less force is needed, as well as less cervical spine movement; less hemodynamic stress response to laryngoscopy and intubation; a short learning curve; and a generally higher success rate, especially in difficult situations.

Image: The CoPilot VL+ video laryngoscope (Photo courtesy of Dilon Technologies).

Soft Robotic Sleeve Supports Heart Function new study describes a proof-of-concept soft robotic sleeve that augments cardiac function in order to support a failing heart.

Under development at Boston Children’s Hospital (MA, USA; www.childrenshospital.org) and the Wyss Institute for Biologically Inspired Engineering (Boston, MA, USA; wyss.harvard.edu), the implantable robotic system involves a septal anchor, a bracing bar and sealing sleeve that pass through the ventricle wall, and a frame embedded with soft actuators mounted around the ventricle. Anchoring of the frame to the interventricular septum is designed to cause approximation of the septum to the free ventricular wall during systole, and assist with recoil in diastole.

Physiological sensing of the native hemodynamics enables rhythmic loading under organ-in-the-loop control of the robotic implants, thus providing fully autonomous augmentation of heart function. The researchers demonstrated the concept on both right and the left ventricles through in vivo studies of a porcine model, with different heart failure

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models used to show device function across a spectrum of hemodynamic conditions associated with right and left heart failure.

In addition, significant reductions in diastolic ventricle pressure were observed, demonstrating improved filling of the ventricles during diastole, enabling sustainable cardiac output. Another benefit is that as the actuator is an external device, blood is squeezed through the heart’s own chamber, and thus could theoretically work with minimal use of anticoagulants. The study was published on November 22, 2017, in Science Robotics.

HF in children is much less common than in adults. While heart transplantation offers effective relief from symptoms, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting its use in children and prolonging the waiting period until transplant can occur. As a result, the median waiting time for a pediatric donor heart in the United States is 119 days. Overall a reported 12-17% of children and 23% of infants die while on the wait list for a heart transplant.

In-Circuit Module Permits Mobile Anesthesia Delivery new mobile anesthesia device delivers inhalation anesthesia in the operating room (OR), intensive care unit (ICU), and even in the field during military operations or disasters.

The Thornhill Medical (Toronto, Canada; http://thornhillmedical. com) MADM in-circuit anesthesia delivery device is designed to make patient anesthesia delivery simpler to monitor and control. While standard anesthesia machines are out-of-circuit devices composed of a complex array of mechanical, electrical, and software-controlled components, the MADM digital device is an in-circuit device that can be added to any ventilator to turn it into an anesthesia machine, with the same vaporizer delivering Isoflurane or Sevoflurane.

Benefits include faster and safer induction, with no need to overpressure the circuit; a rate of induction independent of fresh gas flow; optional use of a reflector to improve efficiency of anesthetic delivery; and faster operator training. The MADM device also serves as a comprehensive anesthetic monitoring device, with information available on anesthetic agent and concentration delivered, end tidal anesthetic concentration, respiration rate, respiratory minute volume (VE), partial inspired CO2 pressure (PICO2), and partial end-tidal carbon dioxide (PETCO2).

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MOBILE RADIOGRAPHY UNIT

X-RAY SYSTEM

ARCOMA

DMS-Apelem

Oehm und Rehbein/OR Technology

The PanoRad features maximum exam flexibility packaged in the smallest footprint. It easily fits in work areas with a ceiling of 2.4 meters as compared to 2.9 meters required for other systems, making it ideal for use in locations with ceiling height restrictions.

The SAXO 4T unit is controlled by a microprocessor and designed for emergency rooms, as well as intensive care and pediatric applications. Using a portable WIFI detector with its tablet, it is possible to easily switch to digital across the mobile fleet.

The Amadeo Cis ceiling-mounted system features a newly designed spring counterbalance system for effortless manual positioning of the X-ray tube. The floating tabletop of the height-adjustable Bucky table is perfectly suited for routine examinations.

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Light and Ultrasound Waves Reveal Extent of Skin Cancer new study demonstrates that multispectral optoacoustic tomography (MSOT) allows three-dimensional (3D) imaging of deep non-melanoma skin tumors (NMSCs).

Developed by the Singapore Bioimaging Consortium (SBIC; www. a-star.edu.sg/sbic), Munich Technical University (TUM; Germany; www.tum.de), the Skin Research Institute of Singapore (SRIS; www. a-star.edu.sg/sris), and other institutions, MSOT is a volumetric imaging technique that can be used to differentiate between tissue chromophores and exogenous contrast agents based on differences in their spectral signatures, and which can provide high-resolution imaging of functional and molecular contrast at centimeter scale depth, providing more precise Mohs micrographic surgery (MMS).

The researchers used handheld MSOT probes for 3D imaging in 21 Asian patients with NMSC. The results showed that both tumors and their oxygenation parameters could be distinguished from normal skin endogenously. Lesion dimensions were extracted from the MSOT spectral melanin component with 3D spatial resolution of up to 80 m, with good correlation to histology of the excised tumors. Real-time 3D imaging also provided data on lesion morphology and the neovasculature, both indicators of the tumorâ&#x20AC;&#x2122;s aggressiveness. The study was published in the September 2017 issue of Photoacoustics.

MMS is a surgical technique for the removal of certain cutaneous carcinomas that allows precise microscopic marginal control. It has become the treatment of choice for several NMSCs, such as basal cell and squamous cell carcinomas at high risk for local recurrence. Advantages of MMS include superior cure rates, maximal tissue conservation, low cost

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relative to that of radiation therapy, excision, or surgery, and negligible risk of complications from general anesthesia.

Image: A 3D rendering of a basal cell carcinoma lesion (melanin in yellow, hemoglobin in blue, and oxyhemoglobin in red) (Photo courtesy of M. Olive et al).

Overweight Women May Need More Frequent Mammograms new study suggests that women with higher body mass index (BMI) may need shorter intervals between mammography screening exams.

Researchers at the Karolinska Institutet (KI; Solna, Sweden; www. ki.se) conducted a study involving 2,358 cases of invasive breast cancer incident between 2001 and 2008 in order to identify risk factors associated with tumors remaining undetected until larger than two centimeters, and to examine long-term prognosis as a factor of percent density (PD), body mass index (BMI), and patient characteristics. The main outcome measure was detection of tumor sized larger than two centimeters, as compared to smaller tumors.

The results revealed that for screen-detected cancers, both BMI and PD were associated with having a large tumor at diagnosis. However, for interval cancers, only BMI was associated with having a large tumor, while PD was associated with having a small tumor. Women with a

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higher BMI had a worse prognosis than women with lower BMI, but only among interval cancers, while large tumors were associated with worse prognosis than smaller ones. The study was presented at the annual meeting of the Radiological Society of North America (RSNA), held in November 2017 at Chicago (IL, USA).

Numerous studies suggest that obesity increases the relative risk of postmenopausal breast cancer. A meta-analysis of 34 cohort studies that included over 2.5 million women shows that a 5-unit increase in BMI is associated with a 12% increase in risk, and that postmenopausal obese women have a 20-40% increase in risk of developing breast cancer compared with normal-weight women. The higher risks are seen mainly in women who have never used menopausal hormone therapy and for tumors that express hormone receptors. In premenopausal women, by contrast, overweight and obesity have been found to be associated with a 20% decreased risk of breast tumors that express hormone receptors.

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Multiparametric MRI Effective For Fatty Liver Assessment new study concludes that non-invasive multiparametric magnetic resonance imaging (MRI) liver scanning technology could halve the number of potential liver biopsies required.

Researchers at the University of Birmingham (UB; United Kingdom; www.birmingham.ac.uk), the University of Oxford (United Kingdom; www.oxford.ac.uk), and other institutions conducted a study to investigate the performance and cost of the Perspectum Diagnostics (Oxford, United Kingdom; www.perspectum-diagnostics.com) LiverMultiScan multiparametric MRI device, which is designed to enable non-invasive and quantitative liver fat characterization, especially in non-alcoholic fatty liver disease (NAFLD).

For the study, 50 patients and six healthy volunteers underwent multiparametric MRI, blood sampling, and transient elastography within two weeks of liver biopsy. A summary of three biochemical liver characteristics, as well as the LiverMultiScan images, was then compared to histology as the gold standard. The results revealed that LiverMultiScan accurately identified patients with steatosis, stratified those with non-alcoholic steatohepatitis (NASH) or simple steatosis, and reliably excluded clinically significant liver disease. The study was published in the March 2018 issue of Alimentary Pharmacology and Therapeutics.

LiverMultiScan uses MRI data to calculate images of proton density fat fraction, T2, and T1 in the liver, which have been shown to correlate with histological measures of steatosis, hemosiderosis, and fibrosis.

The strong magnetic field in an MRI machine is used to excite water and fat molecules, which relax at different speeds. As they relax, they emit a signal, which is used to create the T1 and T2 MR images. T2 is influenced by iron deposits, which can therefore be used to assess he-

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Mobile Fluoroscopic System Continuously Images Extremities cont’d from cover

extremities imaging system is designed to provide fluoroscopic imaging during diagnostic, treatment, and surgical procedures of the shoulders, limbs, and extremities. The system consists of a C-arm attached to a mobile image processing workstation with a streamlined monitor and integrated keyboard. The C-arm supports a high-voltage generator, X-ray controls, collimator, and a metal-oxide semiconductor (CMOS) flat panel detector (FPD) and an X-ray source monoblock used for image acquisition.

The C-arm is capable of performing linear and rotational motions that allow the user to position the imaging components at various angles and distances with respect to patient extremity anatomy. The C-arm and support arm are mechanically balanced, allowing for ease of movement and capable of being locked in place using an electronically controlled braking system. The workstation is a stable mobile platform that supports the C-arm, image display monitor, processing equipment, recording devices, and power control systems.

An intuitive 24-inch high definition (HD) touch screen controls the system, with user-friendly features that include pinch-to-zoom, notifications that allow a way to identify saved images, a save filter, and an auto-save option that saves all images acquired during an imaging session.

Imaging upgrades include a low-dose rate mode that allows reduction of dose rates by up to 50% (compared to auto mode), while continuing to deliver clinically equivalent images. A high-resolution mode enables clinicians to use full detector resolution.

Fluoroscopy is an imaging technique that uses X-rays to obtain realtime moving images of the internal structure and function of a patient, which is useful for general radiology, interventional radiology, and image-guided surgery. Because the patient must be exposed to a continuous source of X-rays instead of a momentary pulse, a fluoroscopy procedure generally subjects a patient to a higher absorbed dose of radiation than an ordinary (still) radiograph, is it used only when a risk-benefit threshold is exceeded.

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patic iron overload, while T1 is influenced by the type and structural organization of a tissue.

Image: A LiverMultiScan image of a post-bariatric liver (Photo courtesy of Perspectum Diagnostics).

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ULTRASOUND SYSTEM

CT PHANTOM

Siemens Healthineers

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The Luminos dRF Max offers both DF and radiography, covering all general fluoroscopic exams and radiographic exams on the table.

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The X3 uses multi-beam processing technology for a more efficient scanning process. It provides a clear view of the lesions, enabling users to improve diagnosis accuracy and save scanning time.

The Mercury 4.0 Phantom meets all advanced CT testing recommended by AAPM TG-233, including automatic exposure control and noise power spectrum. It includes a stand with a handle and leveling feet, along with a wheeled case.

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MRI Safe for Patients with Implanted Legacy Devices atients with a legacy pacemaker or implantable cardioverter-defibrillator (ICD) system that need to undergo a magnetic resonance imaging (MRI) scan have nothing to fear, according to a new study.

Researchers at the University of Pennsylvania (Penn; Philadelphia, USA; www.upenn.edu) and Johns Hopkins University (JHU; Baltimore, MD, USA; www.jhu.edu) conducted a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1,509 patients who had a pacemaker (58%) or an ICD (42%) that was not considered to be MRI-conditional (also known as a legacy device). Overall, the patients underwent 2,103 thoracic and non-thoracic MRI examinations that were deemed to be clinically necessary.

The pacing mode was changed to asynchronous mode for pacing-dependent patients, and to demand mode for other patients, with tachyarrhythmia functions disabled. Outcome assessments included adverse events and changes in device parameters indicating lead and generator function and interaction with surrounding tissue. The results showed no reports of long-term clinically significant adverse events. Following the MRI scan, the patientâ&#x20AC;&#x2122;s device reset to a backup mode in nine cases (0.4%), of which eight were transient. One pacemaker reset to ventricular inhibited pacing and could not be reprogrammed.

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A decrease in P-wave amplitude was the most common notable change in device parameters (occurring in one percent of patients) immediately after MRI. At long-term follow-up, the most common notable changes from baseline were decreases in P-wave amplitude (4%), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The study was published on December 28, 2017, in the New England Journal of Medicine (NEJM).

Image: A new study shows MRI scans are safe for people with legacy ICDs (Photo courtesy of Getty Images).

Functional Neuroimaging Paves Way for Brain Mapping series of functional near-infrared spectroscopy (fNIRS) devices measure chemical changes in the brain, such as hemoglobin levels and apparent arterial oxygen saturation (aSpO2) in the frontal lobe.

The Spectratech (Yokohama, Japan; www.spectratech.co.jp) OEG-APD series of encephalography instruments are based on hemodynamics modality separation (HMS), which can extract data on blood flow in the scalp that is associated with brain function activity by deducting the regional blood flow component from the total fNIRS signal. The OEG-APD series include four products, the OEG-16, OEG-16H, OEG-SpO2, and the OEG17APD devices, and are intended only for encephalography research.

The OEG-16 device is designed for use on the frontal lobe, and measures changes in in-vivo blood using a multi-channel method that simultaneously utilizes light absorption characteristics of near infrared to red light, depending on the mixture of in-vivo hemoglobin and oxygen. The OEG-16H device offers ultrahigh signal to noise ratio (SNR) technology, which can display ultra-weak pulse waves, while also giving users the ability to perform multi-channel brain localization analysis. It is also provided

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with monitoring and measurement tools, including an index of aSpO2.

The OEG-16H facilitates constant connectivity with 6 light injection points, 6 optical light-receiving points, and 16-channel measure points in a lightweight head module that allows it to translate brain waves into data, while simultaneously measuring hemoglobin from multiple points. The device runs on proprietary software, but can also be operated under Microsoft Windows 7 or 8. The OEG-SpO2 module helps measure hemoglobin changes and aSpO2 occurring at multiple points in the brain, with an emphasis on the frontal lobe. The final device is the best-in-class OEG-17APD, which can measure the head in its entirety.

The prefrontal cortex is considered to be in charge of the orchestration of thoughts and actions in accordance with internal goals, responsible for higher-level processing, such as memory, attention, problem solving and decision-making. When a person is learning a new skill, for instance, neural activity is greater in this region. Increasing evidence shows that in Parkinsonâ&#x20AC;&#x2DC;s disease, profound dopamine depletion not only occurs in the striatum of the brain, but also in the prefrontal cortex, and this may be associated with cognitive and motor deficits.

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Medical Imaging

Compact Radiation System Delivers Conformal Radiation Therapy Treatments ovel pencil beam scanning (PBS) technology uses hyperscanning to deliver faster, sharper, and more robust radiation therapy (RT) treatments.

The Mevion Medical Systems (Mevion; Littleton, MA, USA; www. mevion.com) S250i Proton Therapy System with Hyperscan PBS technology is designed to shape the delivered radiation dose by “painting” tumors spot-by-spot and layer-by-layer with the sub-atomic proton particles. Hyperscan technology helps overcome clinical challenges faced by first generation PBS systems by reducing delivery times to less than five seconds, thus reducing errors resulting that can undermine the high precision of PBS due to the target tumor shifting under normal organ motion, such as breathing.

In addition to Hyperscan, the system utilizes an adaptive, robotically controlled aperture proton multi-leaf collimator (pMLC), which is capable of trimming the edges of the beam at every layer of delivery. This capability can deliver up to a three times sharper drop off in radiation at the delivery field edge, sparing healthy tissue and limiting unnecessary radiation to sensitive locations. As other members of the S250 Series platform, the S250i includes a gantry mounted superconducting synchrocyclotron, a six degree-of-freedom treatment couch, and advanced in-room image guidance.

“Delivering sharp field edges has been a real challenge for PBS, especially in shallow fields. In intracranial procedures, where critical structures are in close proximity to tumors at shallow depths, having the sharpest lateral penumbra is essential,” said Skip Rosenthal, VP of clinical education at Mevion. “The sharp penumbras of the adaptive aperture system have substantial benefits for these patients. In addition, the

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enhanced speed of Hyperscan PBS could enable greater confidence in treating thoracic tumors.”

Proton therapy is a precise form of RT that uses charged particles instead of x-rays. It can be a more effective form of treatment than conventional radiotherapy as it directs the RT more precisely, with minimal damage to surrounding tissue. Evidence is growing that protons can be effective in treating a number of cancers, in particular in children and young people with brain tumors, for whom it appears to produce fewer side effects such as secondary cancers, growth deformity, hearing loss, and learning difficulties.

Image: The S250i proton therapy system with Hyperscan PBS (Photo courtesy of Mevion Medical Systems).

MRI Helps Determine 3D Architecture of Human Cervix new study describes how three-dimensional (3D) magnetic resonance imaging (MRI) can be used to monitor women for weaknesses in the cervix, helping to prevent miscarriage.

Researchers at the University of Leeds (United Kingdom; www.leeds.ac.uk) conducted a cross-sectional study, which involved high-resolution diffusion tensor MRI (DT-MRI) ex-vivo measurements of seven cervices obtained at hysterectomy for a benign lesion, using a 9.4-T Bruker nuclear magnetic resonance (NMR) spectrometer. A deterministic algorithm was used to visualize underlying fiber organization in order to determine the microarchitecture of the human cervix, and identify occlusive structures in the region corresponding to the internal cervical os.

The images revealed a fibrous structure running along the upper part of the cervix, which becomes much more pronounced near to where it joins the womb. The fibers are made of collagen and smooth muscle and form a ring around the upper aspect of the cervical canal. During pregnancy, the fibers provide a strong supporting barrier that keeps the fetus and amniotic sac in place, and prevents microorganisms from entering the uterus. During labor, the body releases chemicals that open the cervix, allowing the fetus to enter the birth canal. The study was published on December 11, 2017, in BJOG. “By applying the imaging techniques that

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have been used on the brain, we can get a much clearer understanding of the tissue architecture that gives the cervix its unique biomechanical properties,” said Mr. Nigel Simpson, associate professor in obstetrics and gynecology at Leeds University.

Water molecules undergo random Brownian motion, also known as diffusion. MRI is sensitive to this motion, as controlled by the b-

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value. When the b-value equals zero, the images are not weighted by diffusion; when the b-value is greater than zero the images are diffusion-weighted. When the diffusion is hindered, by cellular membranes, the myelin shield, etc., the signal is higher. DT-MRI can thus be used to visualize fiber structures, as it can readily differentiate water molecule diffusivities both along and against the fiber.

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PRODUCT NEWS SURGICAL SYSTEM

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PATIENT WARMING SYSTEM

MAGNIFYING LAMP

Qmimed

Cincinnati Sub-Zero

ACEM

The Autoforce generator features more advanced computer algorithms, friendly UI, durable hand piece with detachable metal connector and without restriction of times of use. Other benefits include an ergonomic shear for easier operation.

The SurfaceTemp is designed to maximize pressure redistribution, minimize skin sheer and continuously deliver consistent heat to promote normothermia. It allows caregivers to provide warmth, comfort and pressure relief to patients in the OR.

The Circled LED features scratch-resistant optical glass with a diameter of 120 mm and a magnification of three diopters. It features seven LEDs with an average life cycle of about 50,000 hours that produces a white IRfree light without heat.

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Bariatric Surgery Lowers Psoriasis Risk in Obese Patients new study suggests that bariatric surgery (vertical gastroplasty, gastric banding, or gastric bypass) is associated with a lower risk of developing psoriasis, compared to usual care.

Researchers at Sahlgrenska Academy (SA; Göteborg, Sweden; www.sahlgrenska.gu.se) and the National Institute for Health and Welfare (Helsinki, Finland; www.thl.fi) conducted a study to assess the effect of bariatric surgery on the incidence of psoriasis and psoriatic arthritis (PsA) in participants of the Swedish Obese Subjects (SOS) study, of whom 1,991 underwent bariatric surgery, and 2,018 served as controls; none had psoriasis or PsA at baseline. Psoriasis and PsA diagnoses were retrieved from the Swedish National Patient Register and personal questionnaires.

The results showed that during follow-up of up to 26 years, a total of 174 patients developed psoriasis, including 46 who developed PsA. Bariatric surgery was associated with a lower incidence of psoriasis compared with usual care; no significant difference was detected among the three surgical procedures. In addition, both smoking and a longer duration of obesity were independently associated with a higher risk for psoriasis. No significant difference in the risk of developing PsA was detected when comparing the surgery and the control groups. The study was published on November 27, 2017, in Obesity.

Psoriasis is a chronic skin condition with intermittent relapses characterized patches, papules, and plaques, which usually itch. Plaque psoriasis is the most common form, and typically manifests as red and white scaly

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patches on the top layer of the skin. Psoriasis is linked to many other health problems such as inflammatory bowel disease (IBD), depression, obesity, hypertension, ischemic heart disease, and stroke. Up to one-third of subjects with psoriasis are affected by psoriatic arthritis (PsA), which is characterized by chronic joint and soft tissue inflammation.

Image: A new study asserts bariatric surgery reduces psoriasis incidence (Photo courtesy of Shutterstock).

Gastric Bypass and Sleeve Gastrectomy Equally Effective cont’d from cover

(107 patients) or RYGBP (110 patients) in order to compare the two procedures in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events.

The results revealed that in terms of weight loss, both laparoscopic procedures led to similar results at five-year follow-up. Patients lost 68% of their excess weight after a gastric bypass, and 61% after a sleeve gastrectomy, with BMI falling from 44 to 32 for both. Patients with existing gastric acid reflux benefited more from RYGBP, with symptoms eliminated in 60%, compared to just 25% following sleeve gastrectomy. Associated diseases such as hypertension, diabetes, back/joint pain and depression were also improved, as well as general quality of life. The study was published on January 16, 2018, in JAMA. “We have always paid attention to gastroesophageal reflux (GERD)

when advising patients as to which operation they should get, but 31.8% of the people who received the sleeve procedure saw their acid reflux symptoms increase, compared to just 6.3% of those getting the older bypass procedure,” said lead author Ralph Peterli, MD, of St Claraspital. “As a result of the study, we tell them that every third patient not suffering from GERD before surgery may end up experiencing some degree of it in the long run.”

Bariatric surgery is achieved by reducing the size of the stomach with an implanted medical device such as a gastric band (GB), through removal of a portion of the stomach via a vertical sleeve gastrectomy or through a biliopancreatic diversion with duodenal switch (BPD-DS), or by resecting and re-routing the small intestines to a small stomach pouch (RYGBP). In the United States there is a much greater increase in GB than RYGBP, probably due to the preconception that GB is a “simple and safer” procedure.

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Vapor System Obliterates Obstructive Prostate Tissue new minimally invasive system uses the natural thermal energy stored in steam to treat benign prostatic hyperplasia (BPH).

The NxThera (Maple Grove, MN, USA; www.nxthera.com) Rezum System is based on convective water vapor energy (WAVE) platform technology, which is designed to treat BPH symptoms such as frequency, urgency, irregular flow, weak stream, and straining by delivering steam into targeted prostate tissue. When the water vapor contacts the tissue it condenses, releasing the stored thermal energy, causing the obstructive prostate tissue cells to die. In the weeks following a Rezum procedure, the body’s natural healing response eliminates the treated tissue, shrinking the prostate.

The transurethral thermal therapy can be performed in a clinic or out-patient setting using the simple hand-held device, which delivers radiofrequency (RF) generated thermal therapy, in the form of water vapor, directly to the enlarged, obstructive prostate tissue. As the extra tissue is removed, the urethra opens back up, reducing BPH symptoms and improving the patient’s quality of life. The system also allows men to retain sexual function, unlike surgical BPH treatments, which typically have higher incidences of long-term sexual side effects.

“Studies have documented that 60% of men discontinue use of drug therapy to treat BPH after one year as a result of side effects, including sexual dysfunction, and lower degrees of symptom relief and quality of life,” said Bob Paulson, president and CEO of NxThera.

More than half of all men in their sixties and as many as 90% of men in their seventies and eighties have some symptoms of BPH such as more frequent urination with hesitant, interrupted, or weak stream and urgency and leaking. Severe BPH can lead to more serious problems over time, such as strain on the bladder, urinary tract infections, bladder or kidney damage, bladder stones, and incontinence.

Current treatment options to relieve symptoms associated with BPH include drug therapy or surgical procedures, including removal of the enlarged part of the prostate.

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Image: Transurethral vapor technology treats benign prostate hyperplasia (Photo courtesy of NxThera).

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COLPOSCOPE

SURGICAL TABLE

Firefly Global

MedGyn

NUVO

The DE550 combines a digital video camera with a high magnification lens and multiple ultra-bright LEDs. It streams high-quality live video to a computer, enabling the user to view and record crystal clear images or videos.

The AL-105Z Pro includes a SONY camera, HDMI interface, built-in storage capacity, zoom and mirror functions. Other features include built in LED light source, ultra-bright light with continuous illumination adjustment and built-in green filters.

The V800 features a low-profile base that helps reduce surgeon fatigue during long procedures. It provides C-arm access, self-diagnosis with Instant Error Code display, and a control system that automatically prevents of sectional conflicts.

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MRI-Conditional Surgical Table Advances Hybrid OR new multi-functional operating room (OR) table adapted for magnetic resonance imaging (MRI) will allow neurosurgeons to see critical anatomical detail during surgery, without moving the patient from the operating table.

The innovative surgical table is the result of a collaboration between Hill-Rom Holdings (Batesville, IN, USA; www.hill-rom.com) and IMRIS (Minnetonka, MN, USA; www.imris.com) which melds Hill-Rom’s TruSystem 7500 Surgical Table platform with the IMRIS MR Neuro interchangeable tabletops and it’s head fixation portfolio. The table, which is segmented for optimal patient positioning, is controlled via a remote unit or by using the column control panel.

The new table is an essential component of the IMRIS Surgical Theatre, which features a moving, ceiling-mounted intraoperative MRI, computerized tomography (CT), X-ray angiography, and fluoroscopy imaging solutions for a host of standard neurological operations and minimally invasive surgery (MIS) procedures, including upper c-spine orthopedics, aneurysms, arteriovenous malformation, deep-brain stimulation (DBS), drug-delivery, tumor resection, tumor ablation, chiari malformation, and epilepsy-related procedures.

“Our customers challenged us to develop a premium surgical table to be a key component of the IMRIS Surgical Theatre, with the reliability and flexibility to meet the needs of current and future surgical applications,” said Andrew Flanagan, President and CEO of IMRIS. “Partner-

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ship with Hill-Rom surgical solutions leverages the reliability and advanced features of the TruSystem surgical table platform together with the MR Neuro tabletop and head fixation system. This new offering will become a key part of our mission to optimize the surgical workflow.”

Image: A multi-functional, MRI-conditional table aids complex neurosurgery and enhanced intraoperative scanning workflow (Photo courtesy of Hill-Rom).

Hemostasis Solution Controls Bleeding During Surgery novel handheld device delivers a powder based on collagen to help surgeons achieve hemostatic bleeding control during surgical procedures. The Biom’Up (Saint-Priest, France; www. biomupcom) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.

In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not

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need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.

Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.

Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.

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Surgical Techniques

Supermicrosurgery Helps Combat Post-Surgical Lymphedema wo supermicrosurgery techniques can help reduce the fluid retention caused by damage to the lymphatic system, one of the most serious side effects of cancer surgery.

Refined by surgeons at the Medical University of Vienna (MedUni; Austria; www.meduniwien.ac.at), the two advanced surgical reconstruction techniques allow surgical sutures measuring just 0.3-0.8 mm to be used to reconstruct lymph vessels damaged during excision surgeries, which cannot be sutured using standard methods. Using high-performance microscopes, fluorescent liquids, and fluorescence cameras, surgeons can now treat lymphoedema effectively to decrease limb size, alleviate subjective symptoms and early fatigue, and slow disease progression.

The first technique is lymphovenous bypass, which involves connecting lymph channels that are still intact to adjacent veins by suturing them together. As a result, the lymphatic fluid, which would otherwise permeate into the tissue, can be dissipated via the blood circulation. The second technique, vascularized lymph node transfer, involves transplanting intact lymph nodes and their surrounding tissue into the affected areas. The transplanted lymph nodes and vessels not only to absorb lymphatic fluid, but also release growth factors to stimulate the formation of new lymph vessels.

In both techniques, which can also be combined, the lymph channels are marked with a fluorescent fluid that can demonstrate where the lymph channels run, so that breaks are clearly visible under the surgical microscope. Key aspects of both procedures include correct patient selection, using a precise no-touch, atraumatic lymph harvesting technique, undertaking aggressive adhesionolysis in the area of injury, and meticulous microsurgical technique.

“These operations require a very experienced microsurgeon using

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Titanium Fiber Plates Advance Bone Tissue Repair new study claims that titanium fiber plates, unlike conventional ones, do not cause bone embrittlement, which could eliminate the need for plate extraction and the associate surgical risks.

Developed at Shinshu University (Matsumoto, Japan; www.shinshu-u. ac.jp) the new plates are formed by molding titanium fibers into plates by simultaneously applying compression and shear stress at normal room temperature. As a result, the titanium fiber plates show a nearly identical measurement of stiffness (Young’s modulus) as that of natural bone, compared to conventional plates, which have a Young’s modulus four to 10 times higher. A difference in stiffness levels can eventually causes bone embrittlement due to stress shielding.

But as the titanium fiber plates have an elastic modulus similar to that of bone cortex, stress shielding will not occur, even when the plate lies flush against the bone’s surface. In addition, the titanium fibers can form a porous scaffold structure suitable for cell adhesion. In rat studies, osteoblasts combined with the titanium fiber plate were better able to facilitate bone tissue repair than the conventional titanium plate when implanted into bone defects. The study was published on January 25, 2018, in Advanced Materials.

“Our titanium fiber plates, unlike conventional titanium plates are prepared by compressing titanium fibers at normal room temperature into plates without changing the fiber shape,” said lead author Takashi Takizawa, MD, of the department of orthopedic surgery at the Shinshu University School of Medicine.

Most commonly used to hold bones in place while they heal, titanium plates are erosion resistant and strong enough to hold the mending bones in place. But in many cases titanium plates are removed after the healing has finished, as they can cause stress shielding leading to bone embrittlement after close contact with the bone for prolonged periods.

In contrast, titanium fiber plates may be permanently placed, without removal surgery.

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specialized instruments and a modern, high-performance microscope.

The suture material is thinner than a hair and the needle so fine that you cannot see it with the naked eye,” said Christine Radtke, MD, of MedUni Vienna and Vienna General Hospital. “These lymphatic surgery techniques are still relatively unknown, even in the specialist world.

However the procedure is worthwhile, since patients describe immediate pain reduction and a significant improvement in their everyday life.”

Chronic lymphedema is most common in breast cancer patients treated with a combination of surgery, chemotherapy, and radiation, but can occur in all forms of cancer requiring full lymph node dissection in order to determine if further chemotherapy or radiation treatment is necessary. If too many lymph fluid channels are removed, downstream lymph fluid becomes trapped, leading to the lymphedema, which has traditionally been managed with a combination of physical therapy and compression bandages.

Image: Research shows supermicrosurgery surgical reconstruction of lymph vessels reduces lymphedema (Photo courtesy of MedUni).

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OR TABLE EXTENSION

SUCTION UNITS

3D Systems

Allen Medical

Alsa Apparecchi Medical

The Simbionix RobotiX Mentor includes complete robotic clinical procedures with true-tolife graphics and tissue behavior. It provides surgeons with an opportunity to practice the skills required to perform robotic-assisted procedures.

The Allen Spine System enables surgeons to perform spine surgery with the positioning benefits of a standalone spine table. It offers intraoperative lumbar flex and repositioning of the patient and C-Arm and O-Arm access.

The Supersuction 4T series is characterized by high vacuum/high flow suction pumps and high suction speed. They share several common characteristics, but have different suction group and standard accessories.

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Microrobotic Instruments Expand Surgical Intervention Portfolio robotic platform specifically designed for open microsurgery can potentially offer improved surgical success rates and patient outcomes. The Medical Microinstruments (MMI; Calci, Italy; www.mmimicro.com) wristed micro-surgical instruments are equipped with a miniature articulated wrist with a three-millimeter outer diameter and grasping tips just 150 micron in width. The surgeon operates the two microinstruments while looking through an operating microscope as the robotic platform captures the surgeon’s hand movements, imposing an identical, scaled-down motion on the robotic microsurgical instruments, allowing easy manipulation of small sutures ranging from 90 to 12-0 in size.

The microsurgical instruments are manufacture using advanced materials and novel microfabrication processes, resulting in tools that allow the motions of the human hand to be scaled down by almost 20-fold, while still maintaining the dexterity of the natural movement of the human wrist, and at the same time reducing the inherent motion tremor by robotic control. The robotic microinstruments can thus enable such delicate procedures as submillimeter arterial anastomosis and lymph reconstruction.

“We have developed this groundbreaking technology together with microsurgeons from the product’s conception, and the positive feedback and response that we’ve received along the way has really been overwhelming and led us to believe that we are on the right track in devel-

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oping a robot by and for microsurgeons,” said Hannah Teichmann, cofounder and clinical VP of Medical Microinstruments.

“In my opinion, the MMI robotic platform will push the frontier of microsurgery forward and beyond the capabilities of the human hand, thus allowing more surgeons to perform more complex procedures, but also enabling supermicrosurgery, such as lymph reconstruction, for the more expert ones,” said MMI clinical advisor Professor Marco Innocenti, MD, chief of plastic and reconstructive microsurgery at Careggi University Hospital (Florence, Italy). Professor Innocenti recently presented preclinical work with MMI’s robot at the 2017 World Society for Reconstructive Microsurgery annual congress.

Image: Miniature robotic instruments open new frontiers in robotic surgery (Photo courtesy of MMI).

Migraine Surgery Offers Dramatic Functional Improvements new study claims that in addition to reducing headache frequency and severity, surgical treatment for migraine leads to significant improvements in everyday functioning and coping ability.

The study, by researchers at Harvard Medical School (HMS; Boston, MA, USA; https://hms.harvard.edu), Massachusetts General Hospital (MGH; Boston, USA; www.massgeneral.org), and Academic Medical Center (AMC; Amsterdam, The Netherlands; www.amc.nl) prospectively enrolled 90 migraine patients who underwent surgery and completed the Migraine Headache Index (MHI) and pain self-efficacy questionnaire (PSEQ) preoperatively and at 12 months postoperatively. The final analysis included 74 patients who completed both questionnaires at one-year follow-up.

The results revealed that preoperative pain coping scores in migraine patients were substantially lower than those of patients with other types of chronic pain, such as neuropathic, arthritis, or lower back pain. All scores improved significantly from baseline; while average preoperative PSEQ score was 18.2, the improvement following migraine surgery was

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112%, higher than that seen in other pain conditions. Preoperative PSEQ scores did not influence postoperative outcome. The study was published in the January 2018 issue of Plastic and Reconstructive Surgery.

“The PSEQ successfully demonstrates the extent of debility in migraine surgery patients by putting migraine pain in perspective with other known pain conditions,” concluded senior author William Gerald Austen, Jr, MD, of MGH. “It further evaluates functional status, rather than improvement in migraine characteristics, which significantly adds to our understanding of outcome. Poor preoperative PSEQ scores do not influence outcome, and should not be used to determine eligibility for migraine surgery.”

Migraine surgery involves deactivation of certain trigger points by surgical decompression of the peripheral sensory nerves around the skull. The outpatient procedure is performed under local or general anesthesia and usually takes one to two hours. Some patients have multiple migraine trigger points on different areas of the head, and surgery may therefore take longer.

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Surgical Techniques

Topical Skin Adhesive Closes Surgical Incisions novel skin adhesive that offers robust bonding strength, fast sealing, and high flexibility offers an alternative to traditional wound closing techniques.

The Grünenthal (Aachen, Germany; www.grunenthal.com) Flix adhesive is a polyurethane-based, ready-to-use surgical sealant with a unique set of features that allow its use in a broad variety of application areas. These include high-strength adhesiveness to ensure safe wound closure until the wound healing is completed; a honey-like viscosity that allows for an easy and targeted application; and a biocompatible composition that causes no exothermic reaction, itching, or redness, thus providing the basis for good cosmetic results and maximum patient comfort.

Flix has two main components, provided pre-packaged in a twochambered syringe; an entirely synthetic polyurethane prepolymer, which is functionalized with reactive isocyanate groups, and an aminobased curing agent. A poly-addition reaction begins as soon as the components are mixed in the syringe’s static mixing unit. Once mixed, application of the product generates a transparent film that is easily applied to the injured tissue. The components cure quickly, adhering to the tissue via both mechanical and physical adhesion.

The syringe’s spreader tip also allows for a broad and targeted application over the wound site. Once in place, a strong polymer network is quickly formed and full polymerization is completed within a few minutes. As Flix comes prepackaged as a single-use two-chamber syringe,

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Novel Surgical Robot Streamlines Implant Placement robotic surgical trajectory guidance and navigation platform integrates intra-operative computerized tomography (CT) and fluoroscopic imaging technologies.

The Globus Medical (Audubon, PA, USA; www.globusmedical.com) Excelsius GPS robotic surgical platform is designed to support minimally invasive and open orthopedic and neurosurgical procedures, including screw placement applications for spinal surgery. The system includes a computer controlled robotic arm, hardware, and proprietary software to enable real time surgical navigation and robotic guidance using the patients radiological images, including preoperative computerized tomography (CT), intraoperative CT, and fluoroscopy, using a dynamic reference base and positioning camera.

The navigation and guidance system determines the registration or mapping between the virtual patient and the physical patient; once the registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images, helping to guide planning and approach. The information of the plan, coupled with the registration, provides the necessary information for visual assistance during free hand navigation or during automatic robotic alignment of the end effector.

During surgery, Excelsius GPS tracks the position of system compatible instruments, including the end effector of the robotic arm, continuously updating the instrument position on patient images utilizing optical tracking. The system software controls all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. The system uses proprietary re-usable registration instruments, patient reference instruments, surgical instruments, and end effectors such as awls, drills, drivers, taps, and probes.

“Excelsius GPS is another example of continued innovation from Globus Medical, utilizing feedback from expert surgeons from different specialties,” said Norbert Johnson, vice president of robotics, imaging, & navigation at Globus Medical. “Our goal with the Excelsius GPS System is to improve the continuum of care for patients, surgeons, and hospitals through the application of robotic and navigation technology in the fields of spine, trauma, and cranial surgery.”

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application can be completed in less than 60 seconds; this permits nearinstant instant use, even in the case of emergencies. In addition, the adhesive can be stored at room temperature, obviating thawing or preparation prior to use.

“With devices and technologies like surgical sealants we broaden our portfolio beyond the development of new chemical entities in focus areas of high unmet medical need, that is pain and inflammation,” said Gabriel Baertschi, CEO of Grünenthal. “We believe Flix will provide an innovative alternative to traditional wound closing techniques. Through its high flexibility it may enhance patient comfort after surgery.”

Image: A polyurethane surgical adhesive closes surgical sites (Photo courtesy of Grünenthal).

PRODUCT NEWS MEDICAL DISPLAY

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MEDICAL-GRADE TABLET

MEDICAL TABLET

Ampronix

Advantech

Radcal

The MODALIXX G202MDL is designed for enhanced clarity and brightness in LED-lit images offering user-friendly OSD, low power consumption, and wide viewing angle. It is ideal for cath lab, MRI, CT, CR, PET, RF, Carm, and portable X-ray applications.

The AIM-55 is designed to streamline hospital workflows and improve patient care. Its functionalities can be expanded with the addition of extension modules such as barcode scanner, magnetic stripe reader, smart card reader, and RJ45 connector.

The AGTABKEX features a 10-inch multitouch display and keyboard for additional ease of use. It comes with Excel 2013 pre-installed and is designed to run in the Windows environment and interfaces to the Accu-Gold family through USB or WiFi.

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UK National Health Service Hires Hackers to Staff Cybersecurity Unit he UK National Health Service (NHS, London; www.nhs.uk) has committed £20 million on a central cybersecurity unit that will use ethical hackers to probe for weakness in the health service’s computer systems.

The newly formed Security Operations Centre (SOC) will monitor UK national health and care services, including a monitoring service to analyze threats and inform appropriate organizations and individuals on how to prepare for cyber-attacks. The SOC will also carry out on-site security assessments for NHS organizations as well as specialist support in order to identify potential weaknesses, and swiftly deal with potential incidents. The ethical hacking aspect will include attempted hacking of NHS systems, starting with the central NHS Digital infrastructure and expanding to individual hospitals upon request.

That cybersecurity unit was formed in the wake of the WannaCry ransomware attack,

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which hit medical devices and other connected technologies at one-third of NHS hospitals in England in May 2017, with a message informing the user that files have been encrypted, and a demand of USD 300 in bitcoin within three days, or USD 600 within seven days. Up to 70,000 devices, including computers, MRI scanners, blood-storage refrigerators, and theatre equipment may have been affected. The NHS was criticized at that time for maintaining thousands of computers in 42 separate NHS trusts running on Windows XP, and failing to mount a coherent response to WannaCry. Ethical hackers (also known as white hats) find and exploit vulnerabilities and weaknesses in various systems. An ethical hacker’s role is similar to that of a penetration tester, but it involves broader duties, such as employing social engineering techniques to gain access to crucial information or playing the kindness card to trick employees to part with their passwords. An ethical hacker will attempt to evade

intrusion detection systems, intrusion prevention systems, honeypots, and firewalls. An ethical hacker attempts the same types of attacks as a malicious hacker would try, such as sniffing networks, bypassing and cracking wireless encryption, and hijacking web servers and web applications.

Image: The NHS has committed to recruiting ethical hackers to impede cyberattacks (Photo courtesy of BigStock).

Smartphone App Remotely Monitors Wound Healing he healing of postoperative surgical wounds can be effectively monitored with a new smartphone app, according to a new study.

Developed at the University of Wisconsin (WISC; Madison, USA; www.wisc.edu), WoundCheck is a remote wound monitoring protocol that uses smartphones to send images of a post-surgical wound, together with a short, patient-administered questionnaire to monitoring staff.

To assess the mobile health application, 40 vascular surgery patients were trained to use it during their inpatient stay. After hospital discharge, they completed the app protocol daily for an additional two weeks. The inpatient team then reviewed submissions daily and contacted patients for concerning findings.

The results showed that 45% of participants submitted data every day for the two-week period, with an overall submission rate of 90.2%.

The daily submissions were reviewed within an average of 9.7 hours of submission, with 91.9% of submissions reviewed within 24 hours. In all, the researchers detected seven wound complications, with one false

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negative. Participant and provider satisfaction was universally high. The study was published on January 19, 2018, in the Journal of the American College of Surgeons (JACS).

“We set out to come up with a protocol where patients could become active participants in their care and allow us to be in closer communication and monitor their wounds after they leave the hospital,” said lead author Rebecca Gunter, MD. “This approach allows us to intervene at an earlier time, rather than waiting for patients to come back in after the problem has already developed past the point of being able to manage it on an outpatient basis.”

Telemedicine offers the opportunity to leverage technology to remotely monitor recovery during the transitional period between hospital discharge and routine clinic follow-up. However, many existing telemedicine platforms are episodic, replacing routine follow-up, rather than equipped for continued monitoring; they include only low-risk patient populations and those who already have access to and comfort with the necessary technology, and transmit no visual information.

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Augmented Reality System Projects Internal Anatomy novel augmented reality system allows imaging data to be displayed directly on a patient’s skin, revealing the inner workings of the body.

Under development at the University of Alberta (UA; Edmonton, Canada; www.ualberta.ca), ProjectDR allows computerized tomography (CT) and magnetic resonance imaging (MRI) scans to be projected directly on a patient’s body, with a motion-tracking system that uses infrared (IR) cameras and markers on the patient’s body to maintain the images correctly oriented, even if the patient moves. In order to keep both internal and external anatomy aligned, the system uses custom software that integrates all system components.

The system has the capacity to present segmented or isolated images, such the lungs or blood vessels alone. Currently, the project is being refined in order to improve automatic calibration, and to add components such as depth sensors, following which it will be deployed in surgical pilot studies. Potential applications include such areas as teaching, surgical planning, physiotherapy, and laparoscopic surgery. ProjectDR was presented at the annual Virtual Reality Software and Technology Symposium, held during November 2017 in Gothenburg (Sweden).

“It’s kind of like if you had a flashlight or something, and you could select a part of the body and show what’s inside; you can think of the projector illuminating that,” said graduate student Ian Watts, MSc, who developed the technology with fellow UA computing science graduate Michael Feist. “If someone was standing, you could shine this projector at them and you could see their rib cage or their spine or some other internal organ like their heart or veins.”

“Even medical professionals can sometimes have trouble telling what’s happening beneath the skin, because everyone is different internally and people may have had previous medical operations,” concluded Ian Watts. “It’s not always best to have them poking and prodding around without the full knowledge of what’s under the skin, so this application would give them that added context.”

Augmented reality is a term for a live direct or indirect view of a physical, real-world environment whose elements are enhanced by computergenerated sensory input such as sound, video, graphics, or GPS data. It is related to a general concept called mediated reality, in which a view of reality is modified – possibly even diminished rather than augmented – by a computer. As a result, the technology functions by enhancing one’s current perception of reality. By contrast, virtual reality replaces the real world with a simulated one.

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Image: Augmented reality can project internal organs on the skin (Photo courtesy of Ian Watts/ UA).

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PRODUCT NEWS MAMMOGRAPHY SOLUTION

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DATA MANAGEMENT SYSTEM

SURGICAL DISPLAY

Fujifilm

Radiometer

Sony

The AMULET Bellus provides fast display of image data and customized reading protocols for precise diagnosis and streamlined workflow. It displays an outline of the breast image and allows for one-click creation of report for patients.

The AQURE Enterprise allows users to connect to, monitor and manage Radiometer America and third-party testing devices. It provides an overview of all devices and notifies immediately of an issue, ensuring seamless integration with the hospital IT platform.

The LMD-X310MD 4K delivers four times the resolution of HD for the true-to-life clarity that’s critical for seeing various nuances of color and detail. The display is considered ideal for general surgery, medical education and training.

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Mobile Health Applications Jeopardize User Privacy majority of health applications do not meet the legal requirements meant to prevent inappropriate and uncontrolled data disclosure to third-party companies.

Researchers at the University of Piraeus (Greece; www.unipi.gr/ unipi/el) and Rovira i Virgili University (URV; Tarragona, Spain; www.urv.cat) conducted a study that evaluated 20 popular mobile health apps available for free on Google Play. App criteria included 100,000 to 10 million downloads and a minimum rating of 3.5 out of 5 points. All chosen apps managed, stored, and monitored users’ biomedical data, including health conditions, diseases, or medical agendas. The researchers then conducted static and dynamic analysis of the apps, along with tailored testing of each application’s functionalities.

The results revealed that only 20% of the analyzed applications stored data on users’ smartphones, with half of the apps also sharing personal data – both text data and multimedia such as X-ray images – with third parties. One in two apps requested and then managed users’ login passwords without a secure hypertext transfer protocol (HTTPs) connection, transmitting users’ health data through standard URL links, thus making the data accessible to anyone with access to those links.

Some apps required access to geolocation data, microphones, camera, contacts list, an external storage card or Bluetooth communication, although the apps’ functionality did not depend on it. In 20% of the cases, the apps either did not refer users to a privacy policy, or the policy

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content was not available in English. After informing app developers about their findings, researchers noticed some issues had been corrected, such as unsafe health data transfers; but other issues, such as app usage data leaks, had not been addressed at all. The study was published on January 29, 2018, in IEEE Access.

“Recent advances in hardware and telecommunications have enabled the development of low cost mobile devices equipped with a variety of sensors. As a result, new functionalities, empowered by emerging mobile platforms, allow millions of applications to take advantage of vast amounts of data,” concluded senior author Agusti Solanas, PhD, of the URV department of computer engineering and mathematics, and colleagues.

Image: Many health apps do not safeguard user data (Photo courtesy of Getty Images).

Apple Watch App Identifies Irregular Heart Rhythms first-of-its-kind research study will use the Apple Watch’s heart rate sensor to collect data on irregular heart rhythms and notify users who may be experiencing atrial fibrillation (AF).

The Apple (Cupertino, CA, USA; www.apple.com) Heart Study app, launched in partnership with Stanford University School of Medicine (CA, USA; med.stanford.edu), is available for download on the Apple App Store to holders of an Apple Watch Series 1 or later, and who are 22 years or older. To calculate heart rate and rhythm, Apple Watch’s sensor uses green light emitting diode (LED) lights flashing hundreds of times per second and light-sensitive photodiodes to detect the amount of blood flowing through the wrist.

The sensor’s unique optical design gathers signals from four distinct points on the wrist, and when combined with powerful software algorithms, the Apple Watch can isolate actual heart rhythms from other incidental noise. As part of the study, if an irregular heart rhythm is identified, participants will receive a notification on their Apple Watch and

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iPhone, together with a free consultation with a study doctor and an electrocardiogram (ECG) patch for additional monitoring.

“Every week we receive incredible customer letters about how Apple Watch has affected their lives, including learning that they have atrial fibrillation. These stories inspire us, and we’re determined to do more to help people understand their health,” said Jeff Williams, COO of Apple. “Working alongside the medical community, not only can we inform people of certain health conditions, we also hope to advance discoveries in heart science.”

AF occurs when the heart’s two upper chambers beat erratically. In one form, paroxysmal AF, patients have bouts of erratic beats that begin spontaneously and usually last less than a week. AAD can control the heart rhythm and symptoms of AF, but many patients do not respond well. AF can lead to serious adverse events such as thrombi traveling from the heart to obstruct arteries supplying the brain, causing stroke, or other parts of the body causing tissue damage.

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Industry News

Health IT

New Fiberoptic Sensors Dissolve in Body new study describes how bioresorbable sensors could be used for in-body monitoring of bone fracture healing and for safer exploration of sensitive organs such as the brain.

Developed at the Polytechnic University of Turin (Italy; www. polito.it), Consiglio Nazionale delle Ricerche (CNR; Trento, Italy; www. tn.ifn.cnr.it), and other institutions, the new sensing element is a modified fiber Bragg grating (FBG) inscribed into a bioresorbable calciumphosphate glass optical fiber using a 193 nm excimer laser. The laser inscription creates a pattern that causes the fiber to reflect a specific wavelength back in the direction from which it came. A modification that tilts the FBG allows some of the reflected light to escape from the fiber core to the cylindrical surface; the back-reflected light can then be monitored.

The researchers created both tilted and standard optical FBGs to understand how the parameters used for inscription affect the grating sensing characteristics. They found that exposing the bioresorbable fiber to ultraviolet (UV) laser light with a given spatial intensity distribution created a corresponding surface relief pattern in the optical fiber volume after dissolution. According to the researchers, the phosphate glass FBG could be used in soluble photonic sensing probes for efficient in-vivo monitoring of vital mechanical or chemical parameters.

The researchers are now performing systematic experiments to better understand how the fiber composition and UV laser irradiation conditions affect the speed at which the fiber Bragg grating dissolves. This information could be used to create fiber Bragg gratings that dissolve within a specific time period; before being used in people, the dissolving and sensing properties of the FBG will need to be studied in animals.

The study was published on February 15, 2018, in Optics Letters.

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Smart Watch Advances Epilepsy Management novel watch uses advanced machine learning to identify convulsive seizures and send alerts to caregivers. The Empatica (Cambridge, MA, USA; www.empatica.com) Embrace device is based on detection of electrodermal activity (EDA), which quantifies physiological changes related to the human sympathetic nervous system. Embrace also includes a gyroscope to measure rotational speed, a 3-axis accelerometer for high sensitivity motion detection, and a peripheral temperature sensor. The device continuously monitors the wearer for grand mal or generalized tonic-clonic seizures, and transmits the data to a paired smartphone via Bluetooth.

From the smartphone, the data is sent to Empatica’s secure servers via Wi-Fi. Alerts warning of abnormal activity are then sent to caregivers through text and phone. The smart monitoring watch also tracks sleep, stress, and physical activity. In a multi-site clinical study, 135 patients admitted to an epilepsy monitoring unit (EMU) were simultaneously observed via video electroencepholagraphy (EEG) and the Empatica device. In all, 6,530 hours of data were recorded, including 40 generalized tonic-clonic seizures. The Embrace algorithm was shown to detect 100% of the seizures.

“It’s been quite the journey, we have worked for years building wearable stress and emotion sensors, and then accidentally discovered we could pick up changes in the skin elicited by brain activity related to the most dangerous kinds of seizures,” said Rosalind Picard, PhD, director of the affective computing group at the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA; www.mit.edu), and Chief Scientist at Empatica. “It has been very meaningful to see this technology move from the lab into the most accurate, beautiful and easy to use sensor on the market.”

Sympathetic system activation increases with stressors, whether physical, emotional, or cognitive. In some medical conditions, including epilepsy, it shows significant increases that are related to specific brain structures activation. As the skin is the only organ purely innervated by the sympathetic nervous system, and not affected by parasympathetic activation, monitoring subtle electrical changes across the surface of the skin can detect increases in sympathetic activation.

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Global Medical Display Market to Exceed USD 2.3 Billion by 2023 he global medical display market is expected to grow at a CAGR of 4.6% from an estimated USD 1.86 billion in 2018 to USD 2.33 billion by 2023, driven by the growing adoption of hybrid operating rooms (ORs), short replacement cycle of medical displays, increasing preference for minimally invasive treatments, and rising number of diagnostic imaging centers. These are the latest findings of MarketsandMarkets (Northbrook, IL, USA; www.marketsandmarkets. com), a global market research company.

On the basis of technology, the LED-backlit LCD displays segment held the largest share of the global medical display market in 2017 due to the high-quality medical images, high power efficiency, long lifespan, and better return on investment offered by LED-backlit LCDs in comparison to CCFL. Based on display color, the color displays segment accounted for the largest share of the medical display market in 2017, driven by the increasing adoption of color displays owing to their features such as high-quality images and multi-modality capability.

On the basis of panel size, the under 22.9-inch panels segment accounted for the largest share of the global medical display market. The growth of this market segment is being driven mainly by advancements in miniature circuits, microcontroller functions, front-end amplification, and wireless data transmission. Based on application, the diagnostic application segment held the largest share of medical display market in 2017, led by the rapidly increasing prevalence of diseases such as cancer and growing number of patients being screened using imaging systems.

Geographically, North America accounted for the largest share of the global medical display market in 2017, followed by Europe. The large market share of the North American region is primarily due to the high penetration of advanced technologies such as hybrid OR technologies, increasing volume of medical screening due to rising incidence/prevalence of various diseases, and replacement of older technologies with advanced display technologies such as OLED.

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APRIL 2018 Asia Health 2018. Apr 2-4; Singapore; www.medlabasia.com 14th Emirates Critical Care Conference. Apr 5-7; Dubai, United Arab Emirates; www.eccc-dubai.com Saudi Healthcare Exhibition 2018. Apr 15-17; Riyadh, Saudi Arabia; http:// saudihealthcare-expo.com Southeast Asian Healthcare & Pharma Show 2018. Apr 17-19; Kuala Lumpur, Malaysia; www.abcex.com Medtec Europe 2018. Apr 17-19; Stuttgart, Germany; KOREA LAB 2018. Apr 17-20; Seoul, Korea; www.korealab.org Exposanita 2018. Apr 18-20; Bologna, Italy; www.exposanita.it/en EuroPrevent 2018. Apr 19-21; Ljubljana, Slovenia; www.escardio.org Frontiers in Cardiovascular Biology 2018. Apr 20-22; Vienna, Austria; www.escardio.org 2018 ARRS Annual Meeting. Apr 2227; Washington, DC, USA; www.arrs. org/AM18 IMTEC Oman 2018. Apr 24-26; Sultanate of Oman; www.medicaltourism fair.com Charing Cross Symposium 2018. Apr 24-27; London, UK; www.cxsymposium. com

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International Calendar nesburg, South Africa; www.africa healthexhibition.com EAES 2018 – European Association for Endoscopic Surgery and other Interventional Techniques. May 30-Jun 1; London, UK; http://eaes.eu

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SEPTEMBER 2018 Building Healthcare Innovation & Design Show 2018. September; Dubai, United Arab Emirates; www.building healthcare-exhibition.com MedEXPO Kenya 2018. Sep 4-6; Nairobi, Kenya; www.expogr.com

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OCTOBER 2018 Medical World Americas 2018. Oct 23; Houston, TX, USA; www.medicalworld americas.com 12th Interventional MRI Symposium 2018. Oct 5-6; Boston, MA, USA; http://imri2018.org 11th World Stroke Congress. Oct 17-20; Montreal, QC, Canada; www. world-stroke.org 28th World Congress on Ultrasound in Obstetrics and Gynecology. Oct 2024; Singapore; www.isuog.org ESICM 2018 – Annual Congress of the Euro Society of Intensive Care Medicine. Oct 20-24; Paris, France; www. esicm.org UEG Week 2018 – United European Gastroenterology. Oct 20-24; Vienna, Austria; www.ueg.eu CMEF 2018 – China Medical Equipment Fair (Autumn). Oct 29-Nov 1; Shenzhen; China; www.cmef.com.cn

NOVEMBER 2018 Medica 2018. Nov 12-15; Dusseldorf, Germany; www.medica.de RSNA 2018 – Meeting of Radiology Society of North America. Nov 25-30; Chicago, IL, USA; www.rsna.org

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