Medical Device News Magazine

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

LimFlow Reports First Patient Enrolled in PROMISE II U.S. Pivotal Study

December 10, 2019

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

NON PROFIT December 13, 2019

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.

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EXECUTIVES ON THE MOVE

Charles F. D’Agostino Appointed to RedHawk BOD

Executives

December 10, 2019

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

Market Analysis November 29, 2019

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.

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BREAKING MEDICAL DEVICE INDUSTRY NEWS

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

December 13, 2019

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.

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

December 13, 2019

Expands testing and repair capabilities.

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

December 12, 2019

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

Nihon Kohden Launches Life Scope® SVM-7200 Series Vital Sign Monitor

December 10, 2019

The monitor is designed for outpatient facilities and beds that traditionally are not continuously monitored.

Beat Stress Through New Wearable Device

December 10, 2019

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.

Daavlin Partners with HealthLens

December 10, 2019

New teledermatology service is designed to provide quick diagnosis and treatment to patients with psoriasis, vitiligo or eczema.

Owlstone Medical to Join EU-Funded EPHOR Consortium

December 10, 2019

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.

Verantos Receives a Grant from the National Institutes of Health

December 10, 2019

The grant supports advanced scientific efforts by Verantos to define the clinical phenotype, a detailed view of patient characteristics required for RWE studies.

LimFlow Reports First Patient Enrolled in PROMISE II U.S. Pivotal Study

December 10, 2019

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.

3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo™

December 6, 2019

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.

BVI Acquires Arcadophtha SARL

December 6, 2019

Acquisition of Arcadophtha increases BVI's market position by adding a specialist in vitreoretinal surgical liquids and gases.

Wave Neuroscience Completes Major Brain Treatment Technology Asset Purchase

December 6, 2019

In June 2019, Wave Neuroscience purchased substantially all of the assets from the many different onshore and offshore holding companies under NBRL.

Orpyx® Launches Orpyx SI Sensory Insoles with Remote Patient Monitoring

December 4, 2019

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.

Vicarious Surgical Announces Breakthrough Designation by the FDA

December 4, 2019

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 Reports They Received CE Mark for Diagnostic Panel That Aids in Rapid Identification of Serious, Life-Threatening Infections

December 4, 2019

Nanomix developed the S1 Assay to aid in the rapid detection of serious infections, including sepsis and bacteremia.

Peer-Reviewed Publication Highlights First-of-its-Kind Continuous Monitoring Platform for Intensive Care Units

December 4, 2019

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.

Canon Medical Unveils New Educational Opportunities

December 3, 2019

Customers can access the resources they need, when they need them, through web-based learning tools, mobile-friendly resources and accredited opportunities.

HZO Reports Launch of Next-Generation Innovation in Nano Coating Equipment, Delivering Total Waterproofing Protection

December 3, 2019

The HZO PRO800-PL delivers higher throughput with greater precision to enable lower-cost Plasma-based protective nano coatings

First-Ever Blood Collection Tube for cfDNA/cfRNA & gDNA/RNA Pairing Launched

December 3, 2019

The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.

Enrollment in MOTION Study of Mild® Procedure, a Minimally Invasive Treatment for Lumbar Spinal Stenosis Completed

December 3, 2019

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.

Graftless Bone Transplants Soon to Be Reality: ADAM Takes 3D Bones to Clinical Trials

December 3, 2019

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.

Ethicon Launches VISTASEAL Fibrin Sealant (Human)

ETHICON

December 3, 2019

VISTASEAL is first innovation to emerge from Ethicon's strategic partnership with Grifols, a pioneer in the plasma industry.

Wrap Jira in QMS

December 2, 2019

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.

Researchers from Ben-Gurion University and Cincinnati Children’s Introduce Technology for Removal of Secretions from Airways

December 2, 2019

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

RejuvenAir® System for COPD Patients with Chronic Bronchitis Earns CE Mark

December 2, 2019

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.

Onduo Announced First Peer-Reviewed Publication of Clinical Outcomes in JDST

December 2, 2019

The published article presents data on 740 Onduo participants located in 21 states in the U.S., with 30% living in rural communities.

3D4Medical Acquired by Elsevier

November 27, 2019

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.

EOSedge™ New Generation Imaging System is Launched

November 26, 2019

Regulatory approvals in Europe (CE Mark) Canada and Australia. Pending 510(k) review by the U.S. Food and Drug Administration

New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders

November 22, 2019

The SYMPHONY System includes a differentiated offering of instruments and implants designed for stabilization of the spine in patients undergoing Posterior Cervical Fusion surgery.

VEITHsymposium: Favorable Outcomes with TCAR vs. Carotid Endarterectomy in Patients with Carotid Artery Disease

November 22, 2019

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).

SOMATOM X.cite CT Scanner With Intelligent User Interface Concept Now FDA Cleared

November 21, 2019

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.

Glaukos Completes Acquisition of Avedro, Inc

November 21, 2019

As a result of the acquisition’s close, Avedro’s common stock will now cease to trade on the Nasdaq.

Zilver® PTX® Leads to Fewer Complications and Shorter Hospital Stays Than Traditional Bypass Surgery

November 20, 2019

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)

Baylis Medical Announces First Arctic Front™ Advance Cryoballoon Procedures

November 20, 2019

The first cryoballoon cases were performed by Dr. Dan Musat, a cardiac electrophysiologist at The Valley Hospital in Ridgewood, New Jersey, US.

Mologic Announces Launch of Clinical Trial for Validation of Point-of-Care COPD Exacerbation Alert System

November 20, 2019

The the observational trial known as COPE-WEL has recently started recruitment of 263 patients across 10 centers in the UK.

RECENT NEWS

December 13, 2019

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.

Boston Scientific

December 13, 2019

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.

NON PROFIT

December 13, 2019

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

Expands testing and repair capabilities.

Innovatus Imaging

December 12, 2019

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.

Akili Interactive

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