The Latest Cardiac and Vascular News
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical® announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for the Early Feasibility Study (EFS) of the groundbreaking Durablate™ ablation catheter. The single-arm, observational study is designed to evaluate the safety and effectiveness of the Durablate catheter to […]
PLYMOUTH, Minn., July 31, 2018 (GLOBE NEWSWIRE) — Integer Holdings Corporation (“Integer”) (NYSE:ITGR), a leading medical device outsource manufacturer, announced today that it has received FDA and CE Mark approval for their new radial access introducer, RadialSeal™. The RadialSeal Introducer Kit is founded on Integer’s core technology platforms in guidewires and […]
DUBLIN – July 31, 2018 – Medtronic plc (NYSE:MDT) has received U.S. Food and Drug Administration (FDA) approval for the Implantable System for Remodulin® (ISR) to treat patients with pulmonary arterial hypertension (PAH). Through a first-of-its-kind collaboration, the Medtronic SynchroMed(TM) II drug delivery system and cardiac catheter technologies were leveraged to […]
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 […]
