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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.

Monday, August 19, 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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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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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 Specialized Orthopedics Reaches 10,000 Nail Implant Milestone of the Precice® System for Limb Lengthening

NuVasive Inc.
The Precice system is an internal nail that once implanted, utilizes an External Remote Controller (ERC) to non-invasively lengthen the limb.
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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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SHARE PhotoniCare, Inc., Receives Phase I SBIR Award

PhotoniCare Inc.
This $225,000 Phase I SBIR award will fund a clinical artificial intelligence project related to PhotoniCare's TOMi™ Scope. Carle Foundation Hospital (Urbana, IL) and Innolitics, a development firm that specializes in medical imaging software, are partnering with PhotoniCare on this project.
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Titan Medical Completes Survival Phase of GLP Chronic Procedures with its Single-Port Robotic Surgical System

TITAN MEDICAL INC.
The Company now intends to complete the full GLP studies report and required Summative Human Factors studies, followed by the full Human Factors Evaluation (“HFE”) report to facilitate filing of the Investigational Device Exemption (“IDE”) submission by the end of September.
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joimax® and Red One Medical Create Partnership

joimax®
The partnership enables both companies to continue their missions to improve patient care and surgical outcomes with leading-edge medical technology and devices. 
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Mentice Introduces Software Subscription for its VIST® Endovascular Simulation Platform

Mentice
The VIST® software subscription offers Mentice clients flexible procedure selection and predictable annual pricing while it includes software updates, it eliminates hidden service support costs, and it scales based on customer need.
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Thermo Fisher Scientific Expands Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories

Thermo Fisher Scientific
The portfolio enables clinical diagnostic laboratories to leverage a comprehensive platform for developing sensitive and reliable laboratory developed tests.
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Makani Science Receives First Investment from Koa Accel

Makani Science
The Makani Respiration Monitor™ is designed to comprehensively monitor the presence, rate, and depth of breathing in real-time for virtually any patient via small sensor patches on the chest so the care team can immediately detect and respond to respiratory events.
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Seraph® 100 Blood Filter Receives CE Mark

ExThera Medical Corporation
This CE Mark signifies that Seraph 100 meets the safety and performance requirements for medical devices in the European Economic Area (EEA) as an adjunct to anti-infective therapy, and it gives ExThera access to a market of 500 million people.
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Cardiovascular Systems, Inc. Acquires Gardia Medical Ltd.’s WIRION™ Embolic Protection System

Cardiovascular Systems
Scott Ward, CSI Chairman, President and Chief Executive Officer, said, “The acquisition of the WIRION System further supports our commitment and mission of building a comprehensive portfolio of differentiated products aimed at saving limbs and improving outcomes for patients undergoing complex peripheral interventions.”
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Endobronchial Valve Clinical Trial Results Published in “Blue Journal,” The American Journal of Respiratory and Critical Care Medicine

Olympus Medical Systems Group
For patients with the progressive disability of severe emphysema, improved lung function and quality of life have been seen with lung volume reduction surgery. However, eligibility for such invasive surgery is contingent upon the patient's overall health status and pattern of emphysema, leaving the vast majority of patients ineligible. Less invasive measures are therefore needed. 
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Biomerics Merges With Northeast Laser & Electropolish

Biometrics
The merger will create a metals division of Biomerics, called Biomerics NLE, to provide full-service metal processing to the interventional and surgical medical device markets.
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1-year Follow-Ups and Top-Line Clinical Results from ARTISAN-SNM Pivotal Clinical Study

Axonics Modulation Technologies Inc.
The study results at 1-year demonstrate that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life.
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Rock N Roll Never Dies: Survey Reveals Woodstock Generation Is Feeling the Effects of Their Music-Loving Past

Oticon Inc.
The Harris Poll and commissioned by Oticon, Inc. has found an unintended consequence of that generation’s love for hard-charging, culture-changing rock and roll.
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Two Contracts for Sepsis Test Development Announces MBio Diagnostics

MBio Diagnostics Inc.
MBio’s HJF contract is in collaboration with the Austere environments Consortium for Enhanced Sepsis Outcomes
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Broad Reimbursement Approval in Japan for Senhance Digital Laparoscopy System

TransEnterix Inc.
The reimbursement, which became effective on July 31, 2019, applies to 98 benign and malignant laparoscopic procedures across general, colorectal, gynecologic, bariatric and urologic surgeries at reimbursement rates equivalent to traditional laparoscopy in Category A1. The Senhance received regulatory approval from the Japanese MHLW on May 22, 2019.
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Endotronix Receives FDA Approval for PROACTIVE-HF Pivotal IDE Trial

Endotronix Inc.
The innovative trial is designed to expedite Pre-Market Approval (PMA) of the Cordella Sensor and provide evidence to inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). The company plans to begin enrollment in the trial in the third quarter of 2019.
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Access Scientific, LLC Unveils Partnership with Smiths Medical

Access Scientific LLC
Company reports healthcare providers can benefit from significantly improved access to the clinically superior POWERWAND, shown to reduce CLABSIs and the overall cost of care.
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First TMS Patient Treated Under New Japan Reimbursement Policy

Neuronetics Inc.
Reimbursement for Company's non-drug depression treatment, NeuroStar® Advanced Therapy, enables access for depression sufferers in Japan.
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Global Nasdaq Partner Sanmina Delivers RAP Device to More Effectively Target Cellulite Reduction for Pivotal Trial

Soliton Inc.
The company previously announced the completion of final testing of the device by Sanmina, Corp.  After completing safety testing, they have delivered the devices to the first clinical trial site for the pivotal trial.
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First Persistent Atrial Fibrillation Patient With One Shot+™ Cryoablation Catheter

Adagio Medical Inc.
The company reports the first PsAF patient was successfully treated with its new One Shot+™ cryoablation catheter in a procedure that utilizes only anatomical markers with limited usage of fluorographic imaging and eliminates the need for electromagnetic mapping.
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MediBeacon Enters into $30 Million Investment and Exclusive Commercialization Partnership in Greater China with Huadong Medicine

MediBeacon Inc.
The agreement will provide exclusive rights to MediBeacon's portfolio of assets in Greater China.
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PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm

physIQ
This clearance adds to their expanding portfolio of FDA-cleared cloud-based analytics, which also include QRS detection, heart rate, heart rate variability, atrial fibrillation detection, and their personalized physiology change detection analytic.
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Altris AI Algorithm for Retinal Conditions Detection on Optical Coherence Tomography Scans gets CE-Mark

Altris AI
Altris AI Standard Functionality is ready for preliminary screening of retinal diseases in clinical practice. Altris AI detects retinal pathological signs of more than 30 retinal diseases and classifies them according to severities.
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Clinical Use of the LARIAT® with EpiRAIL™ Procedure for Left Atrial Appendage Exclusion

SentreHEART Inc
The LARIAT with EpiRAIL is an epicardial-only, percutaneous approach to complete and permanent closure of the left atrial appendage in patients with atrial fibrillation & increased risk of stroke.
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First Patients Enrolled in DEEPER OUS Spur Stent Trial

Reflow Medical Inc.
DEEPER OUS is a 100-patient prospective, non-randomized, multicenter trial designed to assess the safety and efficacy of the Temporary Spur Stent System compared to a meta-analysis of published data for percutaneous transluminal angioplasty (PTA) in treating patients with infrapopliteal disease.
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First Implantation Of SPIRA®-O Open Matrix OLIF

Camber Spine Technologies
The SPIRA®-O is a deliberately designed implant with a straight in-line insertion taking advantage of a natural corridor for an oblique, anterior to psoas, approach while the patient is in a lateral position. 
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UV Disinfecting Light Fixtures Proven Effective Against the Superbug C. auris itle

Puro
According to the CDC, this superbug, first identified in Japan in 2009, is of great concern because it is multidrug resistant, it is difficult to identify with standard laboratory methods, and it has caused outbreaks in healthcare settings. 
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Prosthetics for Retinal Stimulation

Okayama University
The current study provides direct evidence for the ability of the photoelectric dye-coupled polyethylene film to elicit electroretinogram-like response and action potential spikes in degenerative retina.
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Tactra™ Malleable Penile Prosthesis Launched by Boston Scientific

The new penile prosthesis is the first new innovation in penile implants in more than 10 years and represents an evolution in the design of malleable penile implants to offer the patient and his partner a more authentic, natural-feeling erection.
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Latest QTbreasthealth Center Now Open within Scottsdale’s Vincere Cancer Center

QTbreasthealth
Defines a new generation of breast imaging for women.
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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

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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Carl J. St. Bernard Appointed President and CEO of CeloNova

Executives
St. Bernard joins the company from Tryton Medical where he held the role of President and CEO
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Minnie Baylor-Henry Appointed to Apyx Medical BOD

Executives
Ms. Baylor-Henry will serve as a Director and as Chair of the newly-created Regulatory and Compliance Committee.
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Orthofix Names Jon Serbousek to Succeed CEO

Executives
Jon Serbousek is a seasoned executive with more than 30 years’ experience in the medical device and biotech industries.
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