The Latest Cardiac and Vascular News
Breakthrough SaaMD enables smartphones to be used as class-leading stethoscopes that capture, analyze and share cardiovascular and pulmonary sound data ST. JOHN’S, Newfoundland–(BUSINESS WIRE)–Sparrow BioAcoustics today announced it has received clearance from the U.S. Food and Drug Administration to market its software that allows smartphones to be used as medical stethoscopes. […]
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways RARITAN, N.J., May 30, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson […]
The FDA has provided valuable feedback to reinforce the proposed clinical development plan of glenzocimab in acute ischemic stroke (AIS) A new Type C consultation with the FDA has been granted on the pharmaceutical development plan In Europe additional scientific advice requests under the PRIME program have been validated by […]
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo in the SOLOIST-WHF […]
AccuRhythm AI algorithms now cleared by FDA for the Reveal LINQ ICM; enhancements made to the AF algorithm for the LINQ II ICM DUBLIN, May 16, 2023 /PRNewswire/ — Medtronic plc (NYSE: MDT) today announced its AccuRhythm™ AI algorithm technology is the winner of the 7th annual MedTech Breakthrough Awards program as the “Best […]
SHANGHAI, May 26, 2023 /PRNewswire/ — Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation. Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. Pulse Medical has been […]
The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, with all three studies underway RARITAN, N.J., May 25, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three […]
Artivion to Receive $18.75 Million Milestone Payment Under Previously Announced Agreement Artivion to Begin Supplying Product to Baxter Under Transitional Manufacturing and Supply Agreement ATLANTA, May 23, 2023 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) granted premarket […]
TactiFlex™ Ablation Catheter, Sensor Enabled™, is the world’s first ablation catheter designed with a unique flexible electrode tip and contact force sensing to treat patients with atrial fibrillation When used with Abbott’s EnSite™ X EP System, physicians have better visualization allowing for more accuracy and precision with the TactiFlex catheter, […]
• Live demonstration of new software at Heart Rhythm Society (HRS) 2023, May 19-21 MARSEILLE, France, May 18, 2023 (GLOBE NEWSWIRE) — Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced that the […]
