PRODUCT LAUNCH

December 13th 2022

Stryker launches Citrefix™ Suture Anchor System

Featuring award-winning Citregen biomaterial designed to support bone regeneration and the natural healing process.

Citrefix is a disposable suture anchor system that features a resorbable biomimetic anchor body. It is made with Citregen, an elastomeric material made from a citrate polymer specially designed to mimic bone chemistry for controlled resorption without chronic inflammation.1 These unique chemical and mechanical properties are designed to help grafted tissue heal and healthy bone to grow when used in orthopaedic surgical applications.2 The sterile-packed set includes a cartridge with preloaded implant and eyelet, a drill bit, a drill guide and pre-assembled inserter.

“By leveraging Citregen’s unique material properties, Citrefix introduces design features that greatly increase its pull-out strength compared to other suture anchors,” said Wayne Berberian, M.D., orthopedic surgeon at the Ankle & Foot Institute in Maywood, N. J. “At the same time, the Citregen material benefits patients’ recovery since it is more easily accepted by the body, so they heal without suffering from the chronic inflammation that may occur with other bioresorbable suture anchors.”

Product Launch

December 19th, 2022

Abbott launches the world's smallest implantable, rechargeable spinal cord stimulation system for chronic pain

Abbott today announced the U.S. Food and Drug Administration (FDA) approval of the company's Eterna™ spinal cord stimulation (SCS) system –the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain. Eterna SCS utilizes Abbott's proprietary low-dose BurstDR™ stimulation, the only SCS waveform technology with the highest level of clinical evidence, proven to reduce pain 23% more than traditional waveform technology approaches.

After the successful launch of Citrelock last year, Citrefix is the second product in Stryker’s expanding portfolio using the material, with additional products expected in 2023. Citregen was awarded the 2022 Technology Innovation and Development Award by the Society for Biomaterials earlier this year.

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"Abbott's low-dose BurstDR stimulation is clinically proven to reduce pain, improve people's ability to perform everyday activities, and reduce emotional suffering associated with pain,"^8 said Timothy Deer, M.D., DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. "Until now, it wasn't available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds – a small, best-in-class rechargeable device with superior stimulation therapy."

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Breakthrough

December 6th 2022

Ultromics receives FDA Clearance for its Breakthrough Device EchoGo® Heart Failure

An AI-based platform that enables precision detection of heart failure with preserved ejection fraction.

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Ultromics’ EchoGo® Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug Administration (FDA) clearance. The news puts EchoGo® Heart Failure in the 7% of devices that have gone on to obtain full marketing authorization after being awarded FDA breakthrough status.

The clinical and technological breakthrough was developed by echocardiography and AI experts from Ultromics, a spin-out of the UK’s University of Oxford, in collaboration with Mayo Clinic. The device uses AI to accurately detect HFpEF from a single echocardiogram image, which accounts for 50% of the 64 million cases of heart failure worldwide and has overtaken heart failure with reduced ejection fraction (HFrEF) as the most prevalent form of the deadly disease.

This development marks a huge leap forward from traditional diagnostic algorithms for HFpEF, a heterogeneous syndrome that can be challenging to identify, and is missed in up to 75% of cases.4 Current approaches include time-consuming and often inconclusive diastolic function assessment, and require a highly specialized, increasingly rare skillset, and often invasive testing. To counter this, EchoGo® Heart Failure has a vital role to play in the future HFpEF landscape.

Fda Approval

December 12th 2022

Agilent Resolution ctDx FIRST Receives FDA Approval as a Liquid Biopsy Companion Diagnostic Test for Advanced Non-small Cell Lung Cancer

Agilent Technologies Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib).

This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics. ctDx FIRST has also been approved by the FDA for tumor profiling of the epidermal growth factor receptor (EGFR) gene for use by qualified healthcare professionals in accordance with professional guidelines in oncology patients with NSCLC.

The ctDx FIRST assay uses novel propriety technology to detect genomic alterations in circulating tumor DNA (ctDNA) from plasma. This minimally invasive approach is preferred by 90% of cancer patients compared to more invasive tissue biopsy tests. In addition, liquid biopsy overcomes some limitations encountered with tissue-based methods providing a notably faster turn-around time to potentially accelerate treatment decisions.

Acquisition

December 20th 2022

Olympus to acquire pioneering cloud-AI endoscopy startup, Odin Vision, signifying strategic next step in the company’s broader digital strategy

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Acquisition enables Olympus to provide advanced AI-powered solutions and data-driven insights that transform patient care and improve clinical and procedural workflows.

The acquisition is a strategic component of Olympus’ broader digital strategy to improve patient care by transforming clinical and procedural workflows. Olympus plans to utilize procedure and clinical data collected and analysed in real-time to provide care professionals with digital solutions that reduce administrative burden, assist point of care clinical decision-making and empower them to deliver the best possible care.

The acquisition complements the company’s Digital Endosuite vision, which envisions the use of AI and other digital technologies to extend the reach of endotherapy and improve patient care pathways. The company aspires to lead the future of digital health by establishing a platform with a broad range of cloudconnected software solutions built by both Olympus and a strong ecosystem of third-party development partners.

Peter Mountney, CEO of Odin Vision commented, “Together with Olympus, we are embarking on an exciting journey to bring the next generation of cloud and AI healthcare applications to patients.”

Appointment

December 19th 2022

Cardinal Health Names Aaron Alt Chief Financial Officer

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Cardinal Health (NYSE: CAH) and its board of directors announced that Aaron Alt will become the company's new chief financial officer (CFO). Alt will succeed interim CFO, Trish English and will report to CEO, Jason Hollar, as a member of the company's Executive Committee effective Feb. 10.

In his capacity as CFO, Alt will lead financial activities across the enterprise, including Financial Strategy, Capital Deployment, Treasury, Tax, Investor Relations, Accounting, and Reporting. Additionally, he will lead the Corporate Development team.

"We're pleased to welcome Aaron as the new CFO of Cardinal Health," said Jason Hollar, CEO of Cardinal Health. "He's an exceptional talent with a breadth of experience across complex organizations that will position him well for this critical companywide role. I'd also like to thank Trish for her contributions as interim CFO and her commitment to help with this transition."

Aaron holds an M.B.A. from the J.L. Kellogg School of Management at Northwestern University, a J.D. from Harvard Law School and a B.A. in History and Political Science from Northwestern University.

Expansion

December 8th 2022

New facility in Hangzhou, China helps pharmaceutical and biotechnology customers more quickly deliver patient therapies

Fda Approval

December 14th 2022

FDA Grants Emergency Use

Authorization for Thermo Fisher Scientific’s Monkeypox Test

Thermo Fisher Scientific, the world leader in serving science, announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours.

Thermo Fisher Scientific, the world leader in serving science, is opening a new facility in Hangzhou, China, as part of its global effort to help companies provide therapies to patients more quickly. The site can address the needs of organizations in China, as well as those outside that country, for biologics and steriles development and manufacturing capabilities in the Asia-Pacific region.

The site incorporates stringent quality control processes that meet or exceed regulatory guidelines established by the China National Medical Products Administration (NMPA), the U.S. Food and Drug Administration, and authorities in Europe and elsewhere.

The TaqPath Monkeypox/Orthopox Virus DNA Kit is also designed for identification of other nonvariola Orthopoxvirus DNA. While positive results are indicative of the presence of DNA from monkeypox virus or other non-variola Orthopoxvirus, clinicians must correlate PCR results with patient history and other diagnostic information to determine infection status.

The Hangzhou site is representative of the global scale of Thermo Fisher’s comprehensive end-toend, contract development and manufacturing capabilities. With this facility and Thermo Fisher’s patients can receive the appropriate treatment quickly. Authorized testing also enables public health agencies to stay one step ahead of the virus by monitoring viral spread and addressing affected populations accordingly.”

“Ensuring that all U.S. laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency,” said Manoj Gandhi, senior medical director for Genetic Testing Solutions, Thermo Fisher Scientific. “This helps expedite availability of results so that current capabilities in clinical packaging and logistics, the company can now offer a seamless end-to-end solution from molecule development through the accelerated delivery of critical medicines to patients.

Expansion

December 9th 2022

Siemens Healthineers opens new Ultrasound manufacturing facility in Košice, Slovakia

Siemens Healthineers opened a new Ultrasound manufacturing facility in Košice, Slovakia, its first in Europe, with an initial capacity of up to 120 systems per week. The company will use this new facility to expand manufacturing capabilities for its ultrasound products, including the Acuson Sequoia and the Acuson Redwood. These products can have a significant impact on how clinicians treat and monitor their patients.

The facility in Košice will manufacture some portion of all general imaging and cardiovascular ultrasound systems and will supplement additional manufacturing facilities in Asia and the United States. The additional manufacturing facility will allow for a reduction of carbon emissions by more than 90 percent by ground shipping products to customers in Europe instead of via air freight from Asia.

“The great advantage of Acuson Redwood is primarily its versatility, easy handling and mobility. It offers superior imaging capabilities for specialist departments as well as general radiology within a single hospital. From the patient’s point of view, there is also a benefit in its quiet operation and in reducing the need for invasive procedures,” says prof. MUDr. Gabriel Valočik, PhD, Head of the 1st Cardiology Clinic at the Faculty of Medicine UPJŠ and ESICD in Košice.

Expansion

December 13th 2022

Trinity Health Michigan has begun construction on a US $238.2 million hospital in the USA

Introduction: Trinity Health Michigan has started construction of a new US $238.2 million replacement hospital in Livingston County, USA.

Features: The 174,000-square-foot hospital will expand patient access and offer an integrated campus of medical and surgical treatment, at its current medical facility in Brighton. The four-story facility will be able to accommodate eight licensed operating rooms, 18 existing short-stay unit beds, and 56 acuity adapted beds.

Additionally, renovations will be made to the current medical centre facility.

The upcoming facility, which is scheduled to open in 2025, will bring top medical specialists and services to Livingston County and the surrounding areas. This will provide a continuum of care in one place.

As a result of the newly designed acuity-adaptable patient rooms, patients will not have to be transferred to different care units.

Acuity-adaptable rooms will provide medical, surgical, and intermediate care in one room throughout the duration of the patient's hospital stay, from admission to discharge. The proposed hospital will offer medical services such as primary care, gynaecological surgery, general medicine, cardiology, orthopedics, and urology, among others.