The Latest Cardiac and Vascular News
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria™ surgical aortic heart valve. This next stage of enrollment is expected to begin within the next month. “We are excited to expand enrollment […]
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™. The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance […]
This is the company’s 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market NEW YORK, Oct. 21, 2020 /PRNewswire/ — Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms […]
EDGEWOOD, Ky., Oct. 15, 2020 /PRNewswire/ — Dr. Mohamad Sinno recently performed the first implantation in the U.S. of a Bluetooth-enabled biventricular implantable cardiac defibrillator (ICD) at St. Elizabeth Edgewood. The new device, the Abbott Gallant, recently received FDA approval for a new technology assessment and is available in only a few centers in the U.S. […]
DUBLIN, Sept. 22, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the TYRX™ Absorbable Antibacterial Driveline Wrap, which is intended to securely hold a percutaneous driveline in patients receiving a ventricular assist device (VAD). […]
Next-generation technology provides easy, effective clot removal from peripheral arterial vasculature EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ Thrombus Retrieval System. […]
Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation DUBLIN, Sept. 9, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility […]
Designation Expedites Physician Access to Device for Patients with Extremely Long and Complex SFA Lesions MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug […]
TARRYTOWN, N.Y., Aug. 12, 2020 /PRNewswire/ — Homozygous familial hypercholesterolemia affects approximately 1,300 patients in the U.S., the vast majority of whom are unable to reach target LDL-C levels with currently available therapies Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a […]
Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance […]
