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, September 14, 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.

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.

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

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

The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies for patients with CAD before each procedure, review cases with colleagues, and ensure everyone has a clear picture of the initial treatment plan.
The clinical trial is designed to evaluate the clinical efficacy of Corvia’s InterAtrial Shunt Device (IASD®) in patients with heart failure and is enrolling patients at more than 100 sites worldwide. Of note, the pivotal Phase 3 study design mirrors commentary within a recent FDA Public Workshop and FDA Draft Guidance for Industry related to using biosensor data.
OncoCell MDx has raised more than $30 million to date in support of its vision to simultaneously detect and stage cancer and other diseases using a single blood sample.
This is the fourth acquisition that Viant has completed in two years to expand its clinical market expertise, global footprint, and portfolio of solutions.
The novel nanoIR3-s Broadband system sets new standards in nano-IR spectroscopy and nanochemical imaging. It provides the broadest, tunable mid-IR spectral range with the highest power and the lowest noise, while also delivering unrivalled correlation to FTIR spectroscopy.
Dr Dake presented new 5-year data on Zilver PTX that Cook Medical gathered from the randomized controlled trial (RCT) performed to obtain FDA approval. Dr Dake was also the global principal investigator for the study.
The partnership ushers in a new world of pre-operative planning, overcoming critical pre-surgical and surgical obstacles to minimize patient morbidity and mortality.
DISQVER® testing has identified pathogens relevant for treatment especially in the case of pathogens that are difficult to cultivate and in the case of patients with prior antibiotic treatment.
has secured reimbursement for the MiniMedTM 670G insulin pump system with the German Federal Association of the Statutory Health Insurances.
The presentation included outcomes of two cohorts - a non-randomized Phase 2 (n=30; 2 international sites, 2 surgeons) and the open label subset (OL; n=26; 20 U.S. sites, 26 surgeons) of the ACCESS study, an ongoing, randomized, controlled, multicenter US Phase 3 trial. 
A new company website and modern brand creative bring to life the company’s mission and new campaign, “Fearlessly Take on Your Fertility.”
Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the award-winning CAM patch will now be offered in a 14-day extended wear version that utilizes the same innovative P-wave focused technology that powers the existing 2-Day and 7-Day CAM product lines.
PAH is classified as a life-threatening or irreversibly debilitating disease because it is characterized by a pErogressive increase in pulmonary vascular resistance that leads to right-sided heart failure and death.
American Society for Gastrointestinal Endoscopy (ASGE) has included WATS3D in its Standards of Practice Committee’s guideline for the screening and surveillance of BE. A copy of the Standards of Practice Committee’s guideline can be found here.
The acquisition is an important next step to further strengthen the capabilities of the growth engine Health & Care.
The exclusive distribution agreement, supported by Terumo's strong commitment, will accelerate commercialization of its ProSense™ cryoablation system to treat breast cancer tumors in Japan and Singapore, pending regulatory approval.
Marathon Medical can now sell PainShield and related supplies to the Veterans Health Administration, the largest integrated health care system in the United States, providing care at 1,255 health care facilities.
The SENZA-PDN study compares HF10 therapy plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States.
Organizations can unify product registrations, health authority correspondence and commitments, and submissions documents on a single cloud platform for one global authoritative source of regulatory information.
11/12/18: Agili-C™ Implant procedure was performed by site PI Eric J. Strauss, MD, orthopedic surgeon,NYU Langone Health's Sports Medicine Center NYC.
The funding will be used to accelerate expansion as compensation programs and health plans utilize PeerWell to tackle the $25B+ orthopedic surgery market.
The randomized-controlled study was designed to evaluate the safety and efficacy of VasQ in improving the Short and Mid-term outcomes of arteriovenous fistulas for hemodialysis versus the standard of care.
"These findings are striking and could transform US transplantation practice, leading to thousands of American patients with kidney failure reaping major health benefits," said Dr Peter Reese, Associate Professor of Medicine and Epidemiology at the University of Pennsylvania.
“Results from our testing indicate our silver-plated nylon dressings can quickly kill C. Auris,” said Amanda Budak, PhD, RN clinical director of Argentum Medical. “We are pleased that lab results show Silverlon to be an effective tool against this dangerous pathogen.”
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.
The Panorama test has been extensively validated in 18 peer-reviewed published­ clinical studies involving more than 170,000 patients.
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.
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.
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.
These two U.S. patents provide protection through at least 2038.  Foreign counterpart applications are filed in many countries around the world.
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.  
"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.
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.
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.
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.
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.
The product is available in most retail pharmacies, and the Wholesale Acquisition Cost is $3002 for a 2-pack.
Clearance granted for two of its latest Pulmonary Function Testing technologies: Vyntus ONE, Vyntus BODY with SentrySuite Software.
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.
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.
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...
has secured reimbursement for the MiniMedTM 670G insulin pump system with the German Federal Association of the Statutory Health Insurances.

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.
"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.
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.
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.
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.
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.
NephSAP is a premiere educational offering for American Society of Nephrology members to help them stay abreast of developing areas of nephrology.
“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."
The lawsuit was filed against Hyperice, Massage Guns and Alyne for violating Theragun's various patents.
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.

MARKET REPORTS

Global Enteral Feeding Devices Market Report, 2019-2024

Rising healthcare costs, a growing number of preterm births, rising geriatric population, the increasing prevalence of chronic diseases, and rising awareness of enteral nutrition are expected to drive market growth during the forecast period.

Global Medical Device Market 2019-2024

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.

Medical Robotic System Market

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...

ASSOCIATION NEWS

Updates to the 2019 Standards of Medical Care in Diabetes

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.

Jeff Shuren, M.D., J.D., Statement on FDA Efforts to Increase Transparency in Medical Device Reporting

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.

AAOS Opposition Statement to Senate HELP Surprise Billing Proposal

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."

EXECUTIVES

Kelly-Falls will work to establish strategies for global supplier management, supplier cost reduction, and global risk mitigation. She has more than 25 years of experience in procurement and supply chain with Ford Motor Group, Rolls-Royce North America, Zimmer Biomet, and others.
With more than 16 years of experience as a founder and executive with digital health start-ups, Tarzy will be responsible for all commercial activities, including sales, customer success, implementation and marketing.
Dzierzbinski joins Orbis International from the International Rescue Committee, where she most recently served as Deputy Chief Financial Officer and oversaw the financial management operations.

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