Cardiovascular / Cardiology

Medtronic, the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation…

SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the TIVUS System for renal artery denervation for the treatment of resistant hypertension, which is defined…

Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software. This is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time…

Adagio Medical, Inc., a leading innovator for the treatment of atrial fibrillation (AF) and ventricular tachycardia (VT), and developer of the intelligent Continuous Lesion Ablation System (iCLAS™), today announced that it has closed a $42.5 million Series E equity financing.  Proceeds from the financing will be used to support the ongoing iCLAS™ Investigational Device Exemption (IDE) trial, accelerate the European VT CE-Mark…

Bristol Myers Squibb (NYSE: BMY) and MyoKardia, Inc. (Nasdaq: MYOK) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash. The transaction was unanimously approved by both the Bristol Myers Squibb and MyoKardia Boards of Directors and is anticipated to close during the…

LIVMOR, Inc., a leading digital health solutions company, announced today that the Company received FDA 510(k) clearance for the LIVMOR Halo™ AF Detection System, a physician-prescribed wearable solution that provides continuous monitoring of pulse rhythms for the detection of atrial fibrillation (AF), on demand during the day and automatically overnight.  Continuous monitoring can significantly enhance the…

Johnson & Johnson Medical Devices Companies today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF). The approval is based on results of a prospective, multi-center study (PRECEPT) which met primary safety and effectiveness endpoints and…

Avinger, Inc., a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Ocelaris next generation image-guided chronic total occlusion (CTO) crossing system.…

Medtronic, a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back…

CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has acquired Ascyrus Medical LLC.  Ascyrus is a Florida-based, privately-held developer of the Ascyrus Medical Dissection Stent, the world’s first aortic arch remodeling device used for the treatment of acute Type A aortic dissections.  The addition of the…