The Latest Cardiac and Vascular News
FREMONT, Calif.–(BUSINESS WIRE)–LifeSignals announced today that it received FDA clearance for its wireless LP1100 Life Signal Patch for enabling the next generation of wearable, healthcare monitoring devices. It is built on two solid technology foundations to provide unprecedented attributes unachieved by another ECG patch product to date. It deploys the […]
VANCOUVER, British Columbia, July 25, 2018 (GLOBE NEWSWIRE) — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the issuance of U.S. Patent No. 10,028,664, which covers aspects of its HeartSentry device. “Today’s news is a big deal for Lexington,” says […]
SHEFAYIM, Israel–(BUSINESS WIRE)–Zebra Medical Vision (http://zebra-med.com/) announces today it has received 510(k) clearance for its Coronary Calcium Scoring algorithm. The algorithm, capable of automatically calculating a patient’s Agatston equivalent coronary calcium score from ECG gated CT scan, provides physicians with important data used in the assessment of the risk for coronary […]
ABBOTT PARK, Ill., July 12, 2018 /PRNewswire/ — Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for a next-generation version of its leading MitraClip® heart valve repair device used to repair a leaky mitral valve without open-heart surgery. The transcatheter clip-based therapy, now on a third generation […]
BOLOGNA, Italy, July 11, 2018 /PRNewswire/ — ANGIODROID Srl, an Italian manufacturer of medical technologies, announces the CE mark for ANGIOPULSE, its first intra-aortic balloon pump (IABP) device. The new ANGIOPULSE IABP incorporates a new system for IABP management based on pressure regulation. Extremely sophisticated, ANGIOPULSE builds on the Italian experience of Angiodroid Srl (angiodroid.com), […]
DUBLIN – July 11, 2018 – Medtronic plc (NYSE: MDT) has received United States Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD(TM) System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The HVAD System is the smallest commercially available LVAD, and […]
PALO ALTO, Calif., July 2, 2018 /PRNewswire/ — ReCor Medical announced today that the US Food & Drug Administration approved the Company’s new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II. Building upon the recent positive results of the Company’s RADIANCE-HTN SOLO study, RADIANCE-II will be […]
SUNNYVALE, Calif.–(BUSINESS WIRE)–Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its next generation family of Sniper® Balloon Occlusion Microcatheters, an innovative system for pressure-directed arterial embolization therapy. […]
BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay […]
SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Avenu Medical, Inc. announced today that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. […]
