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 […]
Regulatory
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 […]
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 […]
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 […]
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 […]
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 […]
Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure
MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart […]