The Latest Cardiac and Vascular News
SEOUL, South Korea and BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle […]
IRVINE, Calif., Dec. 20, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced it received approval from the U.S. Food and Drug Administration (FDA) for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation. The Edwards SAPIEN 3 […]
Indication for Pre-Surgical Vein Dilation Use to Promote AV Fistula Creation LAS VEGAS–(BUSINESS WIRE)–Fist Assist Devices, LLC, an innovative medical device company focused on vein dilation to facilitate the Chronic Kidney Disease (CKD) patient’s journey through End-Stage Renal Disease (ESRD), announced today that it received “Breakthrough Device” designation from the […]
Algorithm reduces the volume of false positives from Medtronic implantable loop recorders by nearly 80% to boost medical staff productivity by focusing on meaningful cardiac arrhythmia events CAMBRIDGE, Mass., Dec. 16, 2021 /PRNewswire/ — Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced FDA clearance for a novel […]
World’s Lowest Profile Drug-Eluting Stent Systems with the Lowest Rate of 1 Year Reintervention Reported in a U.S. Pivotal Study Now Approved for Use in U.S. Patients NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–Svelte Medical Systems received U.S. Food and Drug Administration (FDA) approval to commercialize the SLENDER IDS® fixed-wire and DIRECT RX® rapid-exchange drug-eluting […]
Advanced innovations leverage HeartFlow’s core AI technology and are critical additions to HeartFlow’s product portfolio for delivering complete cardiac care REDWOOD CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced it has submitted a 510k premarket application to the U.S. Food […]
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–InterVene Inc. announced today that it has received Breakthrough Device Designation by the FDA for the company’s BlueLeaf® Endovenous Valve Formation System. BlueLeaf is the first catheter-based solution developed for deep vein reflux — the failure of venous valves in the legs — which does not require […]
FDA Granted Designation for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy Based on Results of REDWOOD-HCM SOUTH SAN FRANCISCO, Dec. 09, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive […]
New data shows improved deep learning algorithm performs equally across all age groups, enabling more patients to benefit from the company’s cardiac diagnostics AI platform PARIS and BOSTON, Nov. 22, 2021 /PRNewswire/ — Cardiologs announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform […]
New indication expands addressable market for Pantheris REDWOOD CITY, CA / ACCESSWIRE / November 17, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that it has received 510(k) clearance […]
