The Latest Cardiac and Vascular News
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 […]
Revised Commercial Labeling Broadens Patient Population Who May be Candidates for Transcatheter Aortic Valve Replacement (TAVR) DUBLIN, Aug. 21, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Evolut™ TAVR platform […]
EDEN PRAIRIE, Minn., Aug. 18, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to improving the lives of patients suffering from fluid overload, today announced that its Aquadex™ product line has been added to the Federal Supply Schedule, expanding access to all federal government agencies, […]
HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS™ Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM). Earlier this year, FDA granted NEXUSTM designation as a […]
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 […]
United Imaging now preferred medical imaging partner for MyoStrain® and its unique diagnostic cardiac test. HOUSTON, Aug. 5, 2020 /PRNewswire/ — United Imaging, a global leader in advanced medical imaging and radiotherapy equipment, along with Myocardial Solutions, a medical technology company working to transform the cardiac and cancer care continuum, announced today […]
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed (NASDAQ: ABMD). COVID-19 causes widespread inflammation which can […]
The software significantly improves workflows for analysis, increasing efficiency and reducing costs REDWOOD CITY, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, today announced that it has received a 510(k) clearance from the FDA for its Bioflux Software II System. The software […]
KALAMAZOO, Michigan, USA, Aug. 3, 2020 /PRNewswire/ — Stryker announced today that it has received U.S. Food and Drug Administration (FDA) approval for an expanded indication of its Neuroform Atlas Stent System, becoming the first and only adjunctive stent approved for use in the posterior (back of the brain) circulation. Aneurysms in the posterior […]
