medical device guru

Cardiovascular / Cardiology

SoniVie Receives FDA Breakthrough Device Designation for Therapeutic Intravascular Ultrasound

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...

December 14, 2020

Cardiovascular / Cardiology

Volta Medical Receives FDA Clearance for AI Cardiac Electrophysiology Software

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....

December 10, 2020

Cardiovascular / Cardiology

Adagio Medical Raises $42.5 Million In Series E Financing

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...

November 16, 2020

Cardiovascular / Cardiology

Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash

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...

October 21, 2020

Cardiovascular / Cardiology

Livmor wins FDA clearance for continuous heart monitoring wearable

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...

October 16, 2020

Cardiovascular / Cardiology

J&J’s Biosense Webster gets FDA Nod for Ablation Catheter for Atrial Fibrillation

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...

October 6, 2020

Cardiovascular / Cardiology

Avinger Receives FDA Clearance of Ocelaris Next Generation Image-guided CTO Crossing System

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 &...

September 11, 2020

Cardiovascular / Cardiology

Medtronic Tricuspid Valve Replacement Device Wins FDA Breakthrough Status

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...

September 9, 2020

Cardiovascular / Cardiology

CryoLife Acquires Ascyrus Medical

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...

September 3, 2020