The Latest Cardiac and Vascular News
Eko’s algorithms alert clinicians to the presence of heart murmurs and atrial fibrillation (AFib) during the physical exam, converting the classic stethoscope into a powerful early detection tool SAN FRANCISCO–(BUSINESS WIRE)–Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, announced today that the U.S. […]
One year ago, we received our first 510(k) clearance for ECG for Verily Study Watch — a wrist-worn, sensor-based device for non-invasive, continuous monitoring. Today, we’re thrilled to share that we’ve received a new 510(k) clearance for Study Watch with Irregular Pulse Monitor. This validates our approach at Verily to building robust, clinical […]
Investigative Technology Designed to Interrupt Irregular Pathways in the Heart DUBLIN, Jan. 23, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field […]
WAYNE, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the WattsonTM Temporary Pacing Guidewire – the first commercially available bipolar temporary […]
With FDA Approval, More Patients in the U.S. Are Now Candidates for a Leadless Pacing Option DUBLIN, Jan. 21, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is […]
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces approval from the U.S. Food and Drug Administration (FDA) that the Company has provided sufficient data to support initiating an investigational device exemption (IDE) to […]
SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The Breakthrough Devices Program is designed to […]
JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced […]
SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. has received U.S. Food and Drug Administration approval to proceed with a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral artery disease (PAD) of the lower extremities, a […]
