Saturday, December 14, 2019
Breaking Medical Device Industry News
Saturday, December 14, 2019

Welcome! Medical Device News Magazine reports the latest medical device industry news, clinical trials and updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit Medical Device News Magazine daily.

Clinical Study to Evaluate Device’s Ability to Prevent Amputation and Promote Wound Healing in Patients with No Other Options

The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, MD, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.

Interview with Dr. Dov Rubin, CEO of Lev-El Diagnostics on HeartTrends

Dr. Dov Rubin, CEO of Lev-El Diagnostics talks about how HeartTrends can be used in the early detection of myocardial ischemia, how it differs from traditional stress testing and more.

ASSOCIATION NEWS

Advancements in 3D Printing Technology Bring Promise to Orthopaedic Care

In a new article published in the December issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS), the authors offer an in-depth analysis of the latest 3D printing technology and explore its impact on patient care.

EXECUTIVES ON THE MOVE

Mr. D'Agostino is the retired founder and Executive Director of the LSU Innovation Park and the Louisiana Business & Technology Center ("LBTC") at Louisiana State University and has been actively involved in entrepreneurship, economic development, and technology transfer for the last 30 years

MARKET REPORTS

Global Vascular Grafts Market Industry Analysis, Size, Share, Growth, Trends & Forecast

Presently, synthetic vascular Grafts are most commonly used which are made of either Dacron or Teflon. Increase in incidence of cardiovascular diseases and peripheral diseases is projected to drive demand for vascular grafts.

BREAKING MEDICAL DEVICE INDUSTRY NEWS

The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.
Expands testing and repair capabilities.
Results of the study were presented yesterday at the 58th Annual Meeting of the American College of Neuropsychopharmacology.
The monitor is designed for outpatient facilities and beds that traditionally are not continuously monitored.
Developed by physicians and neuroscientists at the University of Pittsburgh, Apollo’s gentle waves of vibration signal safety to the body through your sense of touch and rapidly improve heart rate variability, a key metric of health and recovery.
New teledermatology service is designed to provide quick diagnosis and treatment to patients with psoriasis, vitiligo or eczema.
The consortium aims to further elucidate the complex relationships between environment and disease by developing the concept of the ‘working-life exposome’, which takes into account all occupational and related non-occupational exposures (e.g. lifestyle) throughout the lifespan of an individual.
The grant supports advanced scientific efforts by Verantos to define the clinical phenotype, a detailed view of patient characteristics required for RWE studies.
The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, MD, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.
Microtia is a rare congenital disorder causing the outer ear (auricle) to be smaller than typical, misshapen, and sometimes missing at birth; most cases only affect one ear.
Acquisition of Arcadophtha increases BVI's market position by adding a specialist in vitreoretinal surgical liquids and gases.
In June 2019, Wave Neuroscience purchased substantially all of the assets from the many different onshore and offshore holding companies under NBRL.
By monitoring pressure, temperature, and movement, the Orpyx SI Sensory Insole system provides the wearer with real-time audiovisual alerts and allows them to immediately take action to resolve high-pressure areas that may lead to tissue breakdown.
The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment.
Nanomix developed the S1 Assay to aid in the rapid detection of serious infections, including sepsis and bacteremia.
The publications provide further support for the ability of the OptiScanner to facilitate enhanced glucose level control in critically ill patients, offering key advantages over traditional, non-automated, labor-intensive glucose monitoring methods.
Customers can access the resources they need, when they need them, through web-based learning tools, mobile-friendly resources and accredited opportunities.
The HZO PRO800-PL delivers higher throughput with greater precision to enable lower-cost Plasma-based protective nano coatings
The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.
The novel prospective, randomized controlled study will collect clinically validated, patient-reported pain and function outcome measures, as well as real-world quality of life data using Fitbit activity trackers.
A Connecticut-based bioprinting startup is piloting the use of ceramics and polymer in 3D-printed bone implants, able to be produced at commodity prices.
VISTASEAL is first innovation to emerge from Ethicon's strategic partnership with Grifols, a pioneer in the plasma industry.
qmsWrapper is an interconnected quality management software for Medical Device Creators to address FDA, CE, ISO compliance and regulatory issues and quality requirements specific to these companies. Intended for small businesses and startups to create safer, better medical devices and help them get to market faster.
Treatment of diseases affecting the respiratory tract, such as bronchiolitis, chronic obstructive pulmonary disease and cystic fibrosis was developed in the framework of the multi-year collaboration between BGU and Cincinnati Children's
The RejuvenAir System is a revolutionary cryosurgical device which applies Metered Cryospray ("MCS") of liquid nitrogen at -196◦C to targeted areas within the lungs through a minimally invasive bronchoscopic procedure. The extreme cold flash freezes damaged surface area lung cells which induces a rejuvenative healing process.
The published article presents data on 740 Onduo participants located in 21 states in the U.S., with 30% living in rural communities.
Elsevier is a global leader in anatomy education and content, with world-leading brands including Netter's Atlas of Human Anatomy, Gray's Anatomy, Sobotta Atlas of Human Anatomy and McMinn & Abrahams' Clinical Atlas of Human Anatomy.
Regulatory approvals in Europe (CE Mark) Canada and Australia. Pending 510(k) review by the U.S. Food and Drug Administration
The SYMPHONY System includes a differentiated offering of instruments and implants designed for stabilization of the spine in patients undergoing Posterior Cervical Fusion surgery.
In a headline presentation, Dr. Mahmoud Malas of the University of California, San Diego School of Medicine shared updated results for the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project contemporaneously comparing TCAR to the surgical standard of care, carotid endarterectomy (CEA).
The intuitive user interface of the myExam Companion guides the user through the exam workflow with precise questions about the patient, potentially enabling optimization of the state-of-the-art features of a premium CT scanner such as the SOMATOM X.cite.
As a result of the acquisition’s close, Avedro’s common stock will now cease to trade on the Nasdaq.
The data, which were gathered from a randomized controlled trial, show that treatment with Zilver PTX results in fewer complications and shorter hospital stays for patients with peripheral artery disease (PAD)
The first cryoballoon cases were performed by Dr. Dan Musat, a cardiac electrophysiologist at The Valley Hospital in Ridgewood, New Jersey, US.
The the observational trial known as COPE-WEL has recently started recruitment of 263 patients across 10 centers in the UK.

RECENT NEWS

World’s First Single-Use Duodenoscope, EXALT™ Model D Receives FDA Clearance

The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.

Advancements in 3D Printing Technology Bring Promise to Orthopaedic Care

In a new article published in the December issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS), the authors offer an in-depth analysis of the latest 3D printing technology and explore its impact on patient care.

Innovatus Imaging Engineers New Repair Solutions for the Philips X5-1

Expands testing and repair capabilities.

Primary Endpoint Achieved in Randomized, Controlled Trial of Digital Therapeutic AKL-T03 in Major Depressive Disorder

Results of the study were presented yesterday at the 58th Annual Meeting of the American College of Neuropsychopharmacology.

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