Friday, July 19, 2019
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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.

Friday, July 19, 2019

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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Merry X-Ray Corporation Announces Significant Shift in Their Sales and Marketing Strategies

Merry X-Ray Corporation
The company will be consolidating all of their existing companies and acquisitions past and present under one strong umbrella identity: MXR The Imaging Solution Company.
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New Research Demonstrates Advantages of ExactechGPS® for Knee and Shoulder Joint Replacement

Exactech
ExactechGPS is a dynamic computer-assisted technology that enhances the surgical experience with active intraoperative feedback for real-time execution in a compact and mobile system within the sterile field.
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BD Provides Update on Voluntary Recalls of Alaris™ Pump Module Model 8100 and Certain Alaris™ Pump Infusion Sets

Becton Dickinson
BD has already notified customers affected by these recalls. Both products were formerly marketed under the CareFusion brand, which BD acquired in March 2015. Both actions have been designated as a Class I recall by the U.S. Food and Drug Administration (FDA). Both recalls have been associated with medical device reporting (MDR) submissions, several of which are associated with serious injuries.
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Parx Plastics Patent Granted for Permanent Implant Application

Parx Plastics NV
Prof. Luigi Costa, PhD, researcher and specialist in Vitamin E-blended UHMWPE biomaterials: “The Parx Plastics technology improving the resistance to adhesion of bacterial biofilms to the surface of orthopedic prostheses parts, represents a further step forward in better controlling the risks of infection.”
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SecurAcath Study of Over 2000 Patients Shows Major Cost Savings Compared to Adhesives

Interrad Medical, Inc.
The study was published in the Journal of Vascular Access in June 2019.
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Submission for IRB Approval of Pivotal Cellulite Trial Protocol

Soliton Inc.
The company expects this larger pivotal trial to form the basis for FDA clearance of their Rapid Acoustic Pulse (RAP) device.
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Cradle Genomics Announces $17 Million Series A

Cradle Genomics
Illumina Ventures and Section 32 led the investment round with participation from Alexandria Real Estate Equities, Sea Lane Ventures, Listwin Ventures, and Axon Ventures.
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Skyhawk Therapeutics Announces Agreement with Genentech

Skyhawk Therapeutics
Skyhawk will use its SkySTARTM platform to develop drug candidates directed to multiple targets for oncology and neurodegenerative diseases. In exchange, Skyhawk will receive an upfront payment and may be eligible for more than $2 billion over time, including opt-in fees and milestone payments plus royalties on sales of commercialized medicines.
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Filterlex Medical Raises $3M in Series A Financing

Filterlex Medical
The company began operating in June 2016 at the Alon MedTech Ventures incubator owned by Dr. Shimon Eckhouse, a pioneer technological entrepreneur and a leading investor in the field of medical devices. Since August 2018 the company is operating independently.
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Novilase Breast Therapy Obtains CE Mark

Novian Health Inc.
"The CE Mark is a significant milestone for Novian Health, as Novilase is the first thermal ablation device approved for treatment of malignant breast tumors," said Henry Appelbaum, president and CEO of Novian Health.
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Endotronix Enrolls First Patient in SIRONA II CE Mark Trial

Endotronix Inc.
“SIRONA II builds on the success of our First-in-Human trial and expands our experience with the Cordella Sensor as we progress towards receiving our CE Mark,” stated Katrin Leadley, MD, Chief Medical Officer of Endotronix.
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LifeSPARC Advanced Circulatory Support System

LivaNova PLC
“LifeSPARC is the new generation pump and controller for the venerable Tandem system – a small but powerful heart pump with a magnetic bearing, a low-profile controller and a highly simplified user interface. I believe many more patients will have access to this higher level of support for the first time,” said Dr. David Baran, System Director for Advanced Heart Failure Transplant and Mechanical Circulatory Support at Sentara Heart Hospital in Norfolk, Va.
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Joe Montana Professional Football Hall of Famer Joins Stimwave Technologies As Official Spokesperson

Stimwave
“After years of dealing with the residual effects of my professional football career, I am excited to have found this battery-free, minimally-invasive alternative to opioids that relieves chronic pain and I’m eager to help other chronic pain sufferers receive this life-changing micro-implant,” said Montana.
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Exablate Neuro With GE SIGNA Premier MR System

INSIGHTEC
The Exablate Neuro is a focused ultrasound platform for treating deep in the brain with no surgical incisions.
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Centerline Biomedical Receives FDA 510(k) Clearance for Intra-Operative Positioning System

Centerline Biomedical Inc.
The system, developed at Cleveland Clinic's Heart and Vascular Institute, addresses the need for a path away from X-ray fluoroscopy which is currently the standard of care, despite severe visualization challenges.
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Treatment Benefits of the remedē® System Sustained Through 36 Months in Patients with Central Sleep Apnea

Respicardia Inc.
The remedē System, which received U.S. Food and Drug Administration (FDA) approval in October 2017, is a breakthrough implantable system that treats the harmful effects of central sleep apnea by restoring a more normal breathing pattern during sleep.
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NuVasive Launches Pulse™

NuVasive Inc.
The company reports Pulse is engineered to improve workflow, reduce variability and increase surgical reproducibility, Pulse addresses a broader range of clinical challenges in the operating room (OR) compared to any other enabling technology in the spine market.
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iSTAR Medical MINIject

iSTAR Medical SA
Company reports The STAR-I trial demonstrated that the implantation of MINIject resulted in a mean pressure of 15.0mmHgat 18-months, consistent with results reported at 1 year, and at a level expected to reduce the progression of glaucoma.
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New Published Study Concludes Triton System Improves Patient Outcome

Gauss Surgical
Researchers at Mount Sinai Hospital in New York City studied over 7,600 deliveries and concluded in "The association between the introduction of quantitative assessment of postpartum blood loss and institutional changes in clinical practice: an observational study" (Katz D, et al.) that the systematic monitoring of blood loss with Triton was associated with improved recognition of postpartum hemorrhage, earlier intervention to control bleeding and cost savings when compared with visual estimation of blood loss.
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ConTIPI Medical Received FDA Approval for Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women

ConTIPI Medical
The Company's developments are a major breakthrough in a market that has been largely neglected in recent years and has lacked any significant clinical innovations in the last 20 years.
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MARKET REPORTS

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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The Infusion Pump Software Market is Expected to Reach $1288.79 Million by 2026

Market Analysis
The Infusion Pump Software market is expected to reach $1288.79 million by 2026 growing at a CAGR of 9.2% during 2018 to 2026.
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Global Prosthetic Heart Valves Market Analysis 2015-2019 & Forecast to 2024

Market Analysis
The report analyzes the worldwide markets for Prosthetic Heart Valves in US$ by the following Segments: Tissue Heart Valves, Transcatheter Heart Valves, and Mechanical Heart Valves.
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ASSOCIATION NEWS

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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ACC Names First Director of Diversity and Inclusion

NON PROFIT
The American College of Cardiology welcomes Ranna Parekh, MD, MPH, as its first Director of Diversity and Inclusion. By working with the ACC Task Force on Diversity and Inclusion and other societies and organizations, Parekh will lead and expand the College’s diversity and inclusion initiatives to create a more diverse and inclusive environment within the field of cardiovascular disease and strive for a fully inclusive organization and profession.
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