medical device guru

Cardiovascular / Cardiology

Implicity Rolls Out AI-Empowered Remote Cardiac Monitoring to Over 10,000 Patients

Implicity, the leading remote cardiac monitoring company in Europe, officially announced its rollout into the US market via its partnership with the Phoenix-based company, IronRod Health. Implicity and IronRod have been nominated for The Prix Galien Medstartup USA in the...

February 21, 2021

Cardiovascular / Cardiology

Vascular Perfusion Solutions Lands FDA Breakthrough Designation for Organ-Transport Device

The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device Designation for its groundbreaking VP.S Encore™ oxygenated perfusion cardiac transport device. The patent-pending technology uses oxygen to enable preserving vascularized tissue for eight...

February 14, 2021

Cardiovascular / Cardiology

Puzzle Medical Receives FDA Breakthrough Device Designation for Transcatheter Heart Pump

Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to...

February 14, 2021

Cardiovascular / Cardiology

Medtronic Wins FDA Approval for DiamondTemp Ablation System

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...

January 30, 2021

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