Regulatory

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 […]

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 […]

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 […]

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, […]

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 […]

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 […]