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Breaking Medical Device Industry News

Medical Device News Magazine

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.

Saturday, August 24, 2019

Three Questions Medical Product Business Owners Should Ask About Private Investments

By: John Geis, Principal of Cresset Partners

Owners of privately held medical product companies who either want to take their businesses to the next level or be rewarded for their years of hard work through a liquidity event often look to private investments to make that happen, since the money flowing into medical product companies is substantial. For example, in the medical technologies space, the average deal size in 2017 was $605 million.

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Video: Physician Reactions to Latest TCAR Data at VAM 2019

At the recent Society for Vascular Surgery Vascular Annual Meeting, significant clinical study results were presented for TransCarotid Artery Revascularization (TCAR) that physicians say will challenge carotid endartectomy (CEA) as the standard of care.
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VAM TCAR Data and Predictions for the Future of Carotid Artery Treatment

It’s Time to Prioritize Surgeons’ Quality of Life

For starters, the Association of American Medical Colleges forecasts a deficit of between 33,500 and 61,800 surgeons and specialists by 2030.

Op-ED By Robert Marema, M.D., is Director of Bariatric Surgery, Flagler Hospital Bariatric Center, Saint Augustine, Florida

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Op-Ed: Groundswell Pushing FDA to Stop Mercury Amalgam Use in Children

FDA’s failed amalgam policy contrasts with other nations protecting children

By Charles G. Brown, Executive Director of Consumers for Dental Choice and president of the World Alliance for Mercury-Free Dentistry

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Neurostimulation with ALARA™ Access Needle Kit Receives FDA Clearance

he ALARA system is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the first instrument used to perforate the pedicle wall before advancing a guidewire, tap or pedicle screw.
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Panorama NIPT Achieves 2 Million Test Milestone

The Panorama test has been extensively validated in 18 peer-reviewed published­ clinical studies involving more than 170,000 patients.
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Endometrial Tissue Sampler Receives CE Mark

CrossBay Medical Inc.
The ETS is the third CrossBay Medical, Inc. product using the frictionless CrossGlide™ technology to receive marketing authorization. The product will be made available for use in endometrial biopsy procedures in the coming months.
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Clinical Study Published in Prenatal Diagnosis Further Validates Vanadis®

PerkinElmer Inc.
The study demonstrated that cfDNA testing with the highly automated Vanadis NIPT system does not require specialized personnel for screening. The Vanadis system is also designed to help reduce cost and allow wider population-based screening.
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iLink® Wearable Sensor Launched

Intellirod Spine
iLink is designed to provide objective data on wearing compliance. iLink is a Bluetooth-enabled sensor module that can be attached to any brace, orthotic or prosthetic to measure wearing compliance, upright posture time and mobility daily through a free smartphone app.
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New U.S. Patents Issued to Third Pole Therapeutics

Third Pole Therapeutics
These two U.S. patents provide protection through at least 2038.  Foreign counterpart applications are filed in many countries around the world.
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Terason Partners With DiA Imaging Analysis to Bring Superior AI Cardiac Solutions to Point-of-care Ultrasound

Terason
The partnership fills a market need for more accurate and objective image analysis for clinicians in hospitals and outpatient settings, that commonly analyze ultrasound images visually.  
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Dreal® Technology Now Available to Spine Surgeons at Scripps Health

Carevature Medical Inc.
"We're proud to be working with surgeons and staff at a prestigious medical system such as Scripps towards providing a unique technology that allows surgeons to safely remove bony pathologies at all levels of the spine, while preserving adjacent soft tissue and bone," said Carevature's VP of marketing and sales Bob Cook.
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Initial Cases With Narrow Width Offerings of the PROLIFT® Expandable Spacer System

Life Spine
Life Spine reports the PROLIFT Expandable Spacer System is now available in width options from 8mm to 12mm and multiple height options that offer up to 6mm of continuous expansion.
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NuVasive Expands its Advanced Materials Science™ Portfolio

NuVasive Inc.
The availability of Modulus TLIF-A further extends NuVasive's technology offerings in the spinal deformity market given its differentiated ability to provide anterior column support, increase segmental lordosis and maximize capability to restore sagittal alignment.
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OptraSCAN® Granted US Patent for Detecting Tissue Area of Interest in Digital Pathology Imaging

OptraSCAN
The company reports this newly acquired patent pertains to a software system that can detect tissue’s area of interest and can differentiate between a tumor and a non-tumor cell. Furthermore, they believe that this patent is an important milestone in defending their exclusive artificial intelligence and machine learning-based automated image analysis solution; especially created for nuclear & membrane biomarker, immune-oncology, prostate cancer and cytology imaging.
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Innovative Blood Clotting Technology Granted Patent in US

Q-Sera Pty Ltd
Q-Sera’s technology now has patent protection for use in blood collection tubes in the United States, Europe, Japan, China, Mexico, Russia, Canada, South Africa and Australia.
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FDA Generic Equivalent of EpiPen Jr® (epinephrine injection, USP) Auto-Injector, 0.15 mg

Teva Pharmaceutical Industries Ltd
The product is available in most retail pharmacies, and the Wholesale Acquisition Cost is $3002 for a 2-pack.
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FDA Clearance of New Pulmonary Function Testing Technology

Vyaire Medical Inc.
Clearance granted for two of its latest Pulmonary Function Testing technologies: Vyntus ONE, Vyntus BODY with SentrySuite Software.
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DiLumen Ik™ Endolumenal Interventional Knife Receives 510(k) Clearance

The DiLumen Ik™ Endolumenal Interventional Knife, a sterile, single-use, disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.
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New Technology for Assessment and Rehabilitation of Brain Trauma in Athletes

Xtreme Performance Lab
Using advanced brain mapping and analysis software, XPL technology can compare an athlete's brain activity against prior baseline measurements to look for signs of new brain trauma, concussions, and traumatic brain injury.
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Adherium and Summatix Announce Strategic Initiative to Enhance Hailie™ Solution’s Digital Platform Impact

Adherium
Adherium (ASX:ADR) has unveiled its new strategic data-based initiative with Summatix Pty Ltd, with the objective of enabling clinicians globally to enhance their care...
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Commencement of Pivotal Trial to Evaluate New Extended Wear Infusion Set

Medtronic
The goal of the study will be to collect clinical data to support the use of the extended wear infusion set for up to seven days - more than twice the length of time that any infusion set can currently be used.
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Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL® Artificial Disc Compared to Previous Generation Lumbar Discs

The activL Artificial Disc is designed to preserve motion at the treated level of the spine by replicating the performance of the intact intervertebral disc.
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First U.S. Clinical Installation and Patient Scans of the uEXPLORER Total-Body PET/CT System

United Imaging Healthcare Technology Group Co.Ltd.
"We're very proud that UC Davis Health is the site of the first uEXPLORER installation in North America," said Dr. Badawi, chief of nuclear medicine at UC Davis.
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V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

V-Wave Ltd.
The study is enrolling advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline directed medical and device therapies.
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Baxter and COSMED Announce Partnership

BAXTER
The agreement provides that Baxter will bring Q-NRG+ to 18 key countries around the world with potential for further expansion. Q-NRG+ is expected to be available from Baxter in September as part of a phased launch in select European countries, Canada and Australia, with launches in additional markets pending future regulatory approval. Additional terms of the agreement were not disclosed.
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New Data Shows CannTrap Technology Optimizes Cannabis Product Effects

CannRx
The data from a CannRx-sponsored pharmacokinetic animal study shows that using CannTrap with cannabis-derived products increases bioavailability up to 100 percent, while the normal bioavailability of cannabis is around 6 to 18 percent.
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NuVasive Expands its Advanced Materials Science™ Portfolio

NuVasive Inc.
The availability of Modulus TLIF-A further extends NuVasive's technology offerings in the spinal deformity market given its differentiated ability to provide anterior column support, increase segmental lordosis and maximize capability to restore sagittal alignment.
LEARN MORE

ClearGuard HD Caps Recommended for Preventing Bloodstream Infection

Pursuit Vascular Inc.
NephSAP is a premiere educational offering for American Society of Nephrology members to help them stay abreast of developing areas of nephrology.
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Two Recently Published Clinical Studies Show Zip® Surgical Skin Closure Leads to Better Clinical Outcomes

ZipLine Medical
“The Zip closure improved the patient experience, and as a result, I have changed my practice to include Zip closure in all knee arthroplasties,” said Dr. Benner. “Patients reported less pain, improved cosmetic outcomes, and even improved early function by improving range of motion."
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Percussive Therapy Brand Theragun, LLC Files Patent Infringement Lawsuit Against Hyperice, Massage Guns, and Alyne

Theragun
The lawsuit was filed against Hyperice, Massage Guns and Alyne for violating Theragun's various patents.
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Corindus Vascular Robotics Announces Definitive Agreement to Be Acquired by Siemens Healthineers

Corindus Vascular Robotics, Inc.
Mark J. Toland, President and Chief Executive Officer of Corindus. “We believe the transaction will deliver immediate, compelling and certain value to all Corindus stockholders, as well as substantial benefits to our customers.
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MARKET REPORTS

Global Medical Device Market 2019-2024

Market Analysis
The report covers the global leading medical device market suppliers and service providers. The report also assesses medical device market drivers, challenges, and the impact of technology convergence. The report also evaluates the issues specific to connected devices such as security and privacy.
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Medical Robotic System Market

Market Analysis
Global Medical Robotic System market accounted for $6,078.31 million in 2017 and is expected to reach $33,652.34 million by 2026 growing at a CAGR...
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Interventional Neurology: Carotid Artery Stents and Embolic Protection Systems Market Forecast

Market Analysis
This medical market and technology report provides a comprehensive discussion of the global market for carotid artery stents and embolic protection systems.
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ASSOCIATION NEWS

Updates to the 2019 Standards of Medical Care in Diabetes

NON PROFIT
Revisions include updated treatment information for adults and youth with type 2 diabetes and new guidelines for people with diabetes who use continuous glucose monitoring.
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Jeff Shuren, M.D., J.D., Statement on FDA Efforts to Increase Transparency in Medical Device Reporting

NON PROFIT
U.S. Food and Drug Administration's Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.
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AAOS Opposition Statement to Senate HELP Surprise Billing Proposal

NON PROFIT
President Kristy L. Weber, MD, “While the AAOS supports removing patients from the middle of out-of-network billing disputes, we strongly believe that imposing an insurer-controlled rate is not the solution. The Lower Health Care Costs Act represents an unprecedented transfer of market power by the government to insurers and directly threatens the independent practice of medicine."
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EXECUTIVES

Eduard Röösli Appointed CEO of Ebb Therapeutics

Executives
Röösli is a proven leader with a strong track record of success in bringing new consumer and RX products to market, across categories.
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Millar Appoints Dr. Alfred Coats Chairman of the Board

Executives
The combination of Dr. Coats' business acumen and medical device background provides excellent support for the governance of the company's direction and goals.
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Tim Rea pf BGF Appointed as Non-Executive Director at PredictImmune

Executives
Rea has been active in the venture capital and start-up ecosystem for over 20 years across a broad range of sectors, stages and geographies. He is particularly passionate about the application of new, disruptive technologies into the healthcare and life sciences ecosystems.
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John Erb and Greg Fluet Named to Electromed BOD

Executives
John and Greg each bring an extensive background in strategy development, operations and finance and their addition speaks to Electromed’s commitment to penetrate the underserved market for non-cystic fibrosis bronchiectasis with our proven SmartVest® Airway Clearance System
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Steven Duddy Appointed New President/CEO of Corinth MedTech

Executives
Duddy will assume day-to-day leadership of the Company and will also join the Corinth MedTech's Board of Directors.
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BioVentrix Additions

Executives
Thasee Pillay, MBChB has been named Chief Medical Officer for Europe and William Abbott has been named Chief Financial Officer.
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