Rhythm

FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval

– Large, Randomized Controlled ADVENT Trial Designed to Establish New Gold Standard for AF Ablation – MENLO PARK, Calif., Dec. 17, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT […]

FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

LAKE OSWEGO, Ore., Dec. 16, 2020 /PRNewswire/ — BIOTRONIK today announced FDA clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new BIOMONITOR IIIm injectable cardiac monitor (ICM), as shown in a published case report1. Physicians will now have access to daily reports on […]

CardioFocus Announces 10,000 Patients Treated Worldwide

HeartLight Procedure Advances the Treatment of Atrial Fibrillation MARLBOROUGH, Mass., Dec. 15, 2020 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that more than 10,000 patients worldwide have been treated with the HeartLight® Endoscopic Ablation System. The HeartLight System is a revolutionary catheter […]

Baylis Medical Launches 2-French Electrophysiology Catheter in Canada for Deeper Coronary Sinus Mapping

TORONTO, Dec. 15, 2020 /CNW/ – Baylis Medical announced today the Canadian launch of its EPstar Electrophysiology Catheters. The launch enables physicians to reach previously inaccessible areas of the heart for procedure mapping, by making available the smallest diagnostic catheter in the Canadian electrophysiology market. The EPstar catheter family includes a 2F catheter and a […]

How Remote Patient Monitoring is Improving Cardiovascular Disease Patient Outcomes, Reports IDTechEx

BOSTON, Dec. 14, 2020 /PRNewswire/ — Cardiovascular disease (CVD) is the leading cause of death worldwide, with over 17 million per year, according to the World Health Organisation. This represents approximately 31% of global deaths. In addition, CVD represents a great strain on healthcare systems worldwide. Total costs to the economy reach […]

BioSig Achieves First Commercial Sale of Three PURE EP Systems

Sale Marks Milestone for Company’s Commercial expansion at leading Center of Excellence Westport, CT, Dec. 11, 2020 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of […]

MicroPort CRM launches clinical trial to advance the innovative Axone (TM) left ventricular lead

PARIS, Dec 10, 2020 / PRNewswire / – MicroPort Cardio Rhythm Management (CRM) has announced the first enrollment in the Astral-4LV [1] clinical trial to evaluate the safety and efficiency of Axone ™ , a revolutionary and innovative ventricular lead quadruple left. Axone ™ is designed for use in heart failure patients with indications for cardiac resynchronization therapy […]

Acutus Medical Announces CE Mark and European Launch of AcQCross™ Transseptal System, a Fully Integrated Family of Transseptal Crossing Products

Designed to Improve Safety and Efficiency in Any Procedure Requiring Left Heart Access CARLSBAD, Calif., Dec. 10, 2020 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced CE Mark and European launch of their integrated family of transseptal […]

Coala Life Launches First Direct-To-Patient Telecardiology Service

Coala Connect Rx service enables patients to virtually be prescribed a Coala Heart Monitor. The service is covered by most US healthcare plans and offered in partnership with US cardiologists. IRVINE, Calif., Dec. 9, 2020 /PRNewswire/ — Coala Life, the award-winning Swedish innovator of real-time remote cardiac monitoring solutions announces the launch of […]