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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.
Sunday, September 22, 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
PROMISE II is a multi-center, prospective, single-arm study to be conducted in the U.S. and Japan. Using an adaptive statistical design, the study plans to enroll 60 to 120 “no option” CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed out to three years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.
Katana’s novel nested dilator and blade design allows users to gain lateral access in fewer steps and with only a single pass by the lumbar plexus. The design is intended to improve access efficiency and, more importantly, improve outcomes by reducing the incidence of approach-related post-operative complications.
Since June 2019, Defymed and 4 other Strasbourg start-ups from the health sector have benefitted from the intensive support provided by the program to expand their presence in the US market. This program will allow Defymed to support its international expansion by developing new partnerships in the United States.
The results of the 146-patient study demonstrate a significantly greater percentage of wound closure in patients receiving active CDO therapy than those receiving a placebo device in addition to standard wound care with identical dressings, debridement recommendations and offloading. Sites that debrided ulcers in nearly every visit experienced a 240% improvement in the treatment arm over the placebo arm, supporting the importance of debridement as a component of the overall diabetic foot ulcer treatment strategy.
As the U.S. Patent Office recognized, AB Max™ is a unique advancement over our competitor's device since Myco's patent covers the revolutionary pulse-mode feature of the AB Max™ after reviewing our competitors' patent.
Together, the AI2 Incubator and Fujifilm SonoSite will work to improve image analysis, allowing for the interpretation of a much wider range of ultrasound scenarios.
The results of the 146-patient study demonstrate a significantly greater percentage of wound closure in patients receiving active CDO therapy than those receiving a placebo device in addition to standard wound care with identical dressings, debridement recommendations and offloading. Sites that debrided ulcers in nearly every visit experienced a 240% improvement in the treatment arm over the placebo arm, supporting the importance of debridement as a component of the overall diabetic foot ulcer treatment strategy.
The NUsurface® Meniscus Implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the U.S.
MR Solutions’ latest PET-MR imaging system for molecular research provides dual scanning capability which significantly improves the quality of the images and the length of time normally taken to conduct separate imaging studies.
OKRA is a multicenter, prospective, observational registry, designed to measure outcomes of kidney transplant recipients managed with KidneyCare.
“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our RECELL System technology platform. We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement,” said Dr. Michael Perry, Chief Executive Officer of AVITA Medical.
The company is announcing the release of the Fall 2019 platform update, which includes enhancements to risk and document management, as well as a new in-app resource center.
This new technology will empower healthcare professionals and their patients with either type 1 and type 2 diabetes to see accurate glucose levels and trends over time to develop more optimal diabetes therapy plans.
The ARTIS icono biplane system is engineered for optimal utilization in neuroradiology and abdominal imaging, while the ARTIS icono floor is a floor-mounted, single-plane system for vascular, interventional cardiology, surgical, and oncology procedures. Both systems in the ARTIS icono family expand the reach of precision medicine.
LCS has been proven to detect lung cancer at earlier stages, when it’s most treatable, as well as reduce mortality by 20 percent compared to standard chest X-ray.
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.
Stanley Healthcare is simultaneously entering into a commercial agreement with VitalTech™ to resell the VitalCare™ and VitalBand™ product lines.
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.
This new technology will empower healthcare professionals and their patients with either type 1 and type 2 diabetes to see accurate glucose levels and trends over time to develop more optimal diabetes therapy plans.
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.
Consistent with 4WEB's existing product portfolio, CSTS-SA has an open architecture, Advanced Structural Design that incorporates the company's proprietary Truss Implant Technology™.
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 OneDraw™ A1C Test System has Received FDA 510(k) clearance. The news was announced today by Drawbridge Health. The OneDraw A1C Test System is intended...
Tissue Genesis' new fully enclosed and automated Icellator® X system efficiently and reliably isolates stem cells from a patient's fat tissue.
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.
This new kit enables users to collect, manage and report Maurice results with the industry leading Empower® 3 Software from Waters™ Corporation.
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.
MARKET REPORTS
Ampoules & Syringes Worldwide Market Forecast
The rising number of health issues owing to the unhealthy lifestyle is expected to drive the market for ampoules and syringes.
European $11.18 Bn Diabetes Care Devices Market to 2027
The Europe diabetes care devices market is expected to reach US$ 11,184.6 Mn in 2027 from US$ 6,853.3 Mn in 2018. The market is estimated to grow with a CAGR of 5.7% from 2019-2027.
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.
ASSOCIATION NEWS
American College of Cardiology Issues Principles for Overcoming Compensation, Opportunity Inequity
The document is the first in a new series of ACC workforce health policy documents and will serve as guidance for clinicians and administrators to advance the profession toward the goals of fairness, including minimizing and reducing disparities, and improved patient care.
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.
EXECUTIVES
The CEWIT Medical Advisory Board is comprised of renowned medical leaders, business executives, scientists, academic leaders and IT professionals.
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.
Fegelman brings over 20 years of experience as a medical and clinical leader for surgical product development to help ensure end-user perspectives remain central to the development of leading device solutions.
Röösli is a proven leader with a strong track record of success in bringing new consumer and RX products to market, across categories.
