The Latest Cardiac and Vascular News
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 […]
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the New Drug Application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to April 28, 2022. The FDA notified Bristol Myers Squibb on […]
U.S. Food and Drug Administration approval of a clinical trial of Cardialen’s low-energy defibrillation and cardioversion therapy expands the number of leading clinical institutions evaluating its promising MultiPulse™ Therapy. MINNEAPOLIS–(BUSINESS WIRE)–Cardialen, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin a […]
If approved, Jardiance would be the first clinically proven treatment for adults across the full spectrum of heart failure regardless of ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 11, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance® (empagliflozin) 10 […]
– FDA 510(k) Clearance Creates Multi-Vendor, One Click MRI™ Automation Platform to Increase Real-Time MRI Imaging Access and Accuracy for Patients – New AHA and ACC Guidelines, Making Cardiac MRI a Class I Recommendation for Chest Pain, Will Increase CMR Use to Widely Impact the Practice of Cardiology PALO ALTO, Calif.–(BUSINESS WIRE)–HeartVista, […]
