Rhythm

FIRE1 Completes Enrollment in U.S. Early Feasibility Study of Innovative Remote Heart Failure Monitoring System

DUBLIN–(BUSINESS WIRE)–FIRE1 today announced that it has completed patient enrollment in the U.S. Early Feasibility Study (FUTURE-HF2) of its FIRE1™ System for remote heart failure monitoring. The FIRE1 System is the first device designed to directly measure a patient’s volume status by measuring the largest vein in the body where most […]

Volta Medical Receives CE Mark for AF-Xplorer™ Decision support solution to Simplify Complex Atrial Fibrillation Procedures

Proprietary AI companion technology assists electrophysiologists by reducing ambiguity in mapped atrial fibrillation (AF) patterns MARSEILLE, France, Feb. 28, 2024 (GLOBE NEWSWIRE) — Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced CE (Conformité Européenne) Mark according to the new European Medical […]

Biosense Webster Begins Enrollment of Pivotal Trial Evaluating the Laminar Left Atrial Appendage Elimination Device 

Irvine, CA – February 27, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech[i], announced the commencement of patient cases with the investigational Laminar Left Atrial Appendage Elimination (LAAX) System as part of its pivotal investigational device exemption (IDE) study. […]

Pulsed Field Ablation Innovator Argá Medtech Announces €54 Million Oversubscribed Series B Capital Raise

– Funding will advance US and EU clinical studies of innovative pulsed field ablation system for treating atrial fibrillation – LAUSANNE, Switzerland and SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) — Argá Medtech, a private company developing Coherent Sine-Burst Electroporation™ (CSE™), a next-generation cardiac ablation system for treating cardiac arrhythmias, […]

XYRA Announces Successful FDA End of Phase 2 Meeting and Agreement on Endpoints for Approval of Budiodarone for the Management of Atrial Fibrillation

LOS ALTOS, Calif., Feb. 26, 2024 /PRNewswire/ — XYRA LLC, a private biopharmaceutical company committed to developing innovative therapies for cardiac rhythm disorders with high unmet need, is pleased to announce today it has reached agreement with the FDA (“Agency”) at a series of End…

X-trodes Receives FDA 510(k) Clearance for Wearable “Skin” Solution that Brings Medical-Grade Electrophysiological Monitoring to the Home

HERZLIYA, Israel, Feb. 20, 2024 /PRNewswire/ — X-trodes, a bio-convergence company bringing wireless monitoring solutions to the home environment, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for X-trodes’ Smart Skin solution (marketed as X-trodes System M), a new wireless wearable technology for advanced electrophysiological monitoring. X-trodes’ Smart Skin is comprised of customizable dry-printed […]

Canary Completes First-in-Human Trial of Cardiac Auscultation Monitoring Sensor

The Cardiac Auscultation monitoring device was trialed for use with heart failure patients as an adjunct to care in monitoring the effectiveness of congestive heart failure medication management The limited clinical trial represents the first human implantation of a cardiac auscultation sensor device Heart failure affects one in five people, […]

Biosense Webster Supports Collaborative Studies That Aim to Expand Knowledge in Pulsed Field Ablation

Irvine, CA – February 8, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, today announced support for two collaborative studies, VIRTUE and POLARIS. These studies aim to better understand the use and workflows with the investigational VARIPULSE™ Platform for treating […]

Biosense Webster Study Supports Low and Zero Fluoroscopy Workflow as Safe, Effective Alternative to Conventional Catheter Ablation

Retrospective Analysis of Real-World Data Presented as Late-Breaker at 29th Annual International AF Symposium  Irvine, CA – February 1, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, revealed findings from a company-funded study of real-world data. Titled “Real-world Data Affirms […]