News Follows Medtronic Receiving FDA Breakthrough Device Designation for its Valiant Navion™ LSA Branch Thoracic Stent Graft System DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System […]
Peripheral/Endo
PQ Bypass Announces Unconditional IDE Approval From U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2)
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years. MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed […]
Blood Flow Monitoring Device – FlowMet-R Gets FDA 510K Clearance
IRVINE, Calif., Oct. 2, 2019 /PRNewswire/ — Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its blood flow monitoring system, FlowMet-R, received its 510(k) clearance from the Food and Drug Administration (FDA). This clearance allows LAS to market and sell the FlowMet-R. The non-invasive portable device addresses a […]
AngioDynamics Acquires Eximo Medical, Ltd. and its Innovative 355nm Laser Atherectomy Technology
LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that it has acquired Eximo Medical, Ltd., an early commercial stage, medical device company, and its proprietary 355nm wavelength laser-technology platform for $46 million in […]
BD Announces Publication of an Independent Analysis of Drug-Coated Balloon Safety Data for Femoropopliteal Peripheral Arterial Disease
FRANKLIN LAKES, N.J., Sept. 28, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the publication of a company-initiated, independent analysis of the LUTONIX® 035 Drug Coated Balloon (DCB) femoropopliteal clinical program in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. These data were simultaneously presented […]
Intact Vascular Announces Positive One-Year Data from TOBA III Clinical Trial
Growing Body of Evidence Supporting Use of the Tack Endovascular System® to Improve Balloon Angioplasty Outcomes for Patients Suffering from PAD WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive one-year results of its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial, successfully achieving […]
Teleflex Announces Tenth Anniversary of GuideLiner® Catheter Product Line
Company Celebrates 10 Years of the Industry’s Leading Guide Extension Catheter with More Than 1 Million Units Sold Worldwide WAYNE, Pa., Sept. 25, 2019 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the tenth anniversary of its industry-leading GuideLiner® Catheter. Released in November […]
THE SAGE GROUP LLC Comments on National Peripheral Artery Disease (PAD) Awareness Month
BEAUFORT, S.C.–(BUSINESS WIRE)–According to THE SAGE GROUP, in 2015 almost 20 million Americans suffered from PAD representing an economic burden of $224-$414 billion. “Almost 20 years ago, we wrote that PAD was underestimated, underdiagnosed and undertreated,” stated Mary L. Yost, President. “Unfortunately, this is still true.” Reflecting on the current […]
Journal Of Vascular Access Publishes Positive Clinical Results For Bluegrass Vascular’s Surfacer® System
Additional clinical evidence to be highlighted at upcoming Controversies in Dialysis Access (CiDA) and American Society of Nephrology (ASN) meetings SAN ANTONIO, Sept. 24, 2019 /PRNewswire/ — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of positive results associated […]
LimFlow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients
PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption for the PROMISE II pivotal study of the LimFlow Percutaneous Deep […]
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