The Latest Cardiac and Vascular News
RIST Cath device enables a radial approach during neurointerventional procedures for introduction of devices into the neurovasculature MIAMI BEACH, Fla.–(BUSINESS WIRE)–RIST Neurovascular, Inc., a neuro-interventional medtech company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RIST Cath Radial Access Long Sheath™ (RIST […]
First device to reliably and repeatedly achieve central venous access from the inside-out in patients with venous obstructions SAN ANTONIO, Feb. 11, 2020 /PRNewswire/ — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. Food and Drug […]
ATLANTA, Feb. 7, 2020 /PRNewswire/ — CorMatrix®Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced receiving FDA approval to expand and enroll 20 additional patients in the adult arm, including up to 4 additional cardiac surgery research and investigative centers, for its early feasibility IDE study of the Cor® TRICUSPID ECM® valve* for […]
SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to […]
CARMAT has responded to all remaining questions from the conditional approval Number of subjects to be enrolled in the study extended to 10 patients PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for […]
ABBOTT PARK, Ill., Feb. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS). The FDA launched the Breakthrough Devices Program in 2018 to help expedite the development and review […]
– The CATALYST trial will examine Abbott’s Amplatzer™ Amulet™ device compared to non-vitamin K oral anticoagulants, the current standard in attempting to lower stroke and bleeding risks for patients with atrial fibrillation ABBOTT PARK, Ill., Feb. 3, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration […]
CorCinch HFrEF Study Evaluating Safety of AccuCinch Ventricular Repair System in Heart Failure Patients SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of enrollment in its CorCinch HFrEF […]
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. […]
New Larger Implant Enables Focal Dissection Repair Across a Wider Range of Vessel Sizes WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced Food and Drug Administration PMA approval for the expansion of its Tack Endovascular System® (6F) portfolio. The new approved device […]
