The Latest Cardiac and Vascular News
Ascyrus Medical receives Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. BOCA RATON, FLA. (PRWEB) AUGUST 14, 2019 Ascyrus Medical announced today that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) […]
CAESAREA, Israel, Aug. 15, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF). V-Wave’s minimally invasive, implanted interatrial […]
SAN JOSE, Calif., Aug. 13, 2019 /PRNewswire/ — DynoSense Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its patented Vital Signs Measuring System, the world’s first most integrated and cloud-based vital signs measuring and recording platform. Its unique worldwide patented and award-winning design is as simple […]
WARRINGTON, Pa., Aug. 13, 2019 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for istaroxime for the […]
Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its response to the U.S. Food and Drug Administration’s (FDA) Letter to Health Care Providers regarding treatment of peripheral artery disease (PAD) in the superficial femoropopliteal artery (SFA) with paclitaxel-coated devices. Importantly, the FDA recommendation continues […]
BETHLEHEM, Pa., Aug. 01, 2019 (GLOBE NEWSWIRE) — B. Braun Interventional Systems Inc. (BIS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR). SeQuent Please ReX is […]
LISLE, Ill., Aug. 1, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center PROACTIVE-HF trial of the Cordella™ Pulmonary […]
FREMONT, Calif., July 17, 2019 /PRNewswire/ — Q’Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC). In the neurovascular space where speed, reliability and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC […]
WHIPPANY, N.J., July 15, 2019 /PRNewswire/ — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist is […]
