Rhythm

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 […]

Biosense Webster Presents Late-Breaking Data from inspIRE and admIRE Clinical Trials at AF Symposium

Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months in patients with optimal Pulsed Field Ablation applications First look results from admIRE study suggests similar outcomes Irvine, CA – February 2, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part […]

Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System

MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., […]

GE HealthCare Announces Prucka 3 Digital Amplifier as Next Generation Platform for Electrophysiology Innovation

Latest digital platform provides key advancements to help maintain high signal fidelity while reducing environmental noise Forward-looking platform designed to help enable path to new technologies in the electrophysiology (EP) lab Chicago, IL – January 31, 2024 – GE HealthCare (Nasdaq: GEHC) announces the latest innovation in electrophysiology (EP), the Prucka […]

Pulse Biosciences Announces Preliminary Findings from its CellFX nsPFA 360 Cardiac Catheter First-In-Human Feasibility Study to be Featured in Podium Presentation at the AF Symposium

HAYWARD, Calif.–(BUSINESS WIRE)– Pulse Biosciences, Inc. (Nasdaq: PLSE), a company with a primary focus on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field (nsPFA) technology for the treatment of atrial fibrillation, today announced that its nsPFA technology will be featured in a podium presentation at the 29th Annual AF Symposium in […]