Rhythm

TCAI physicians participate in clinical trial for potential life-saving device for patients with heart rhythm disorders

AUSTIN, Texas, Feb. 5, 2021 /PRNewswire/ — Physicians with the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center are among the first in the world to participate in a clinical trial to evaluate a new esophageal protection device designed to make ablation procedures safer for patients with atrial fibrillation (A Fib), the most […]

B-Secur Receives FDA Regulatory Clearance For Its HeartKey® EKG/ECG Technology

Expands portfolio across Health, Wellness and User Identification for deployment in consumer and medical technology sectors BELFAST, Northern Ireland–(BUSINESS WIRE)–B-Secur, a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey® software library1. B-Secur’s HeartKey® is a suite of powerful […]

Sequana Medical Announces Granting of Key alfapump DSR® Patents in U.S. and Europe

GHENT, Belgium, Feb. 04, 2021 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces the granting of key patents for the alfapump DSR (Direct Sodium Removal) programme in the U.S. and European Union. […]

BioSig and Mayo Clinic Collaborate on New R&D Program to Develop Transformative AI and Machine Learning Technologies for its PURE EP™ System

Westport, CT, Feb. 02, 2021 (GLOBE NEWSWIRE) — Global market for AI in healthcare is estimated to reach $45.2 billion by 2026 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 […]

AliveCor Now Detects Six Times as Many Cardiac Conditions as Any Other Personal ECG

Launch of expanded range of determinations cements AliveCor as the most comprehensive AI-enabled solution in personal ECG MOUNTAIN VIEW, Calif., Feb. 1, 2021 /PRNewswire/ — AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, today launched an expanded range of ECG determinations on its KardiaMobile devices. These new determinations are cleared by […]

CardioFocus Announces Expanded Partnership With Japan Lifeline

HeartLight® X3 Japan Launch Anticipated in Mid-2021 MARLBOROUGH, Mass., Feb. 2, 2021 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial fibrillation (AFib), announced today that it has expanded its existing partnership agreement with Japan Lifeline Co., Ltd. (JLL). The agreement extends the timeframe of the existing distribution […]

Medtronic Receives FDA Approval of DiamondTemp Ablation System for the Treatment of Patients with Atrial Fibrillation

Clinical Trial Demonstrates Procedural Efficiencies, Safety, Effectiveness and Non-Inferiority of DiamondTemp System DUBLIN, Jan. 29, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), 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 […]

CathVision clinical results to be presented at the AF Symposium

COPENHAGEN, Denmark, Jan. 29, 2021 /PRNewswire/ — CathVision ApS, a medical device company developing a novel cardiac electrophysiology system and artificial intelligence platform to guide ablation therapy for heart rhythm disorders, is featured at the 26th annual international AF Symposium, held online January 29-31st. On January 30th, Professor Josef Kautzner, Institute of Cardiology and Experimental Medicine […]

FARAPULSE Receives European Approval To Commercialize Its Leading Pulsed Field Ablation System To Treat Paroxysmal Atrial Fibrillation

– FARAPULSE becomes first company in the world to commercialize a cardiac PFA system – MENLO PARK, Calif., Jan. 29, 2021 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced that it has received the Conformité Européene (CE) Mark for its FARAPULSE Pulsed Field Ablation (PFA) system for the treatment of […]

iRhythm Technologies Provides Statement on Medicare Administrative Contractor (MAC) Novitas Recent Rate Publication

SAN FRANCISCO, Jan. 29, 2021 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, commented on the recent publication by Novitas Solutions (“Novitas”) of rates applicable to the Current Procedural Terminology (CPT) codes 93241, 93243, 93245 and […]