The Latest Cardiac and Vascular News
Family of focal ablation catheters are the only approved option to treat specific type of supraventricular tachycardia (SVT) DUBLIN, Feb. 18, 2022 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the Freezor™ and Freezor™ Xtra Cardiac Cryoablation Catheters are approved by the U.S. Food and Drug Administration […]
Niagara Falls, NY , Feb. 17, 2022 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a nuclear medicine PET imaging device systems and clinical services company, is pleased to announce today that the Company has retained Medical Device Academy ”MDA”) as its consultant for the Company’s new […]
– Phase 1/2 clinical trial expected to initiate in mid-2022 – – LX2006 is the first clinical-stage program from LEXEO’s cardiovascular pipeline and the third clinical-stage gene therapy candidate across its pipeline – NEW YORK, Feb. 16, 2022 (GLOBE NEWSWIRE) — LEXEO Therapeutics (LEXEO), a clinical-stage gene therapy company advancing a diverse […]
CHICAGO, Feb. 15, 2022 /PRNewswire/ — Cardiosense, Inc., a Chicago-based digital health company building a physiological waveform AI platform to manage cardiac disease, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for its novel algorithm to identify patients at risk of decompensated heart failure. The algorithm analyzes […]
Comaneci™ temporarily expands blood vessels–recognized as novel device for life-threatening disease YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, today announced FDA breakthrough designation for its Comaneci™ embolization assist device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke. Vasospasm is a major complication and cause of morbidity. […]
WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. Asundexian is an oral inhibitor of Factor Eleven (FXIa) 1 that Bayer is developing […]
Malmö, Sweden, February 9, 2022 Acarix submits breakthrough designation request with FDA for heart failure diagnosis Acarix expands its portfolio and submits a breakthrough designation request for its innovative technology for heart failure diagnosis with the Food and Drug Administration (FDA) in USA. Heart failure affects more than 6 million people in the USA at […]
Company’s reSept™ ASD Occluder Aims to Evolve Septal Closure with its Novel Metal-Free Frame Design BAAR, Switzerland and SANTA CLARA, Calif., Feb. 8, 2022 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start […]
NASHVILLE, Tenn., Feb. 8, 2022 /PRNewswire/ — IVX Health, a national provider of infusion and injection therapy for patients with complex chronic conditions, announced today the expansion of its injection formulary with the addition of Leqvio® (inclisiran), a new FDA-approved therapy by Novartis Pharmaceuticals Corporation indicated for the treatment of adult patients with clinical atherosclerotic cardiovascular disease (ASCVD) […]
BOSTON, Feb. 8, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt System in patients […]
