Regulatory

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 […]

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 […]

Rocket Pharmaceuticals Announces FDA Clearance of IND for Clinical Trial of RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy (ACM)

First clinical gene therapy program for PKP2-ACM, a devastating inherited heart disease affecting approximately 50,000 people in the U.S. and EU Robust preclinical proof of concept studies showed RP-A601 decreased arrhythmias and increased survival in the PKP2 knockout mouse model Initiating Phase 1 trial start-up activities and rapidly working towards first […]

Humacyte’s Human Acellular Vessel™ (HAV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Urgent Arterial Repair Following Vascular Trauma

HAV granted second RMAT designation by the FDA RMAT will support Humacyte’s lead indication in Vascular Trauma DURHAM, N.C., May 04, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, has been recently granted the U.S. Food […]