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 […]
Regulatory
Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system
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 […]
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
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 Announces FDA PMA Approval of PerClot and Transfer of PMA to Baxter
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 […]
Abbott Receives FDA Approval for TactiFlex™ Ablation Catheter for Treatment of Abnormal Heart Rhythm
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, […]
Volta Medical Announces FDA Clearance of Volta AF-Xplorer™ Software to Simplify Complex Atrial Fibrillation Procedures
• 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 […]
Abbott Receives FDA Clearance for Assert-IQ™ Insertable Cardiac Monitor to Help Doctors Monitor People’s Heart Rhythms Long-Term
Abbott’s Assert-IQ offers the world’s longest battery life† for an insertable cardiac monitor (ICM) The latest addition to Abbott’s portfolio of connected health devices, the Assert-IQ ICM offers long-term monitoring and remote programming to improve connectivity to patients The device provides continuous monitoring for abnormal heart rhythms while offering tools […]
FDA Approves Next Generation MicroPort CRM AlizeaTM and CeleaTM Pacemaker Systems
Alizea™ and Celea™ are the world’s longest-lasting pacemakers for their size on the market today1 AlizeaTM and CeleaTM Pacemaker Systems feature AutoMRI™ Mode and Bluetooth®2 Connectivity May 18, 2023 08:00 AM Eastern Daylight Time CLAMART, France–(BUSINESS WIRE)–MicroPort CRM, a global pioneer in the field of Cardiac Rhythm Management, headquartered in France, announced today it […]
Bayer Receives U.S. FDA Fast Track Designation for asundexian Atrial Fibrillation Program
Not intended for UK Media The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an […]
HeartSciences Announces Completion of Patient Enrollment for FDA Pivotal Study of MyoVista wavECG
Southlake, Texas, May 09, 2023 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through the early detection of heart disease, today announces completion of patient enrollment for its MyoVista wavECG pivotal […]



