Rhythm

FDA Grants IDE Approval to Evaluate Attune Medical’s ensoETM in Radiofrequency Ablation Procedures

US Arm of IMPACT II Study Will Ascertain Reduction of Esophageal Thermal Injury During Cardiac RF Ablation Procedures CHICAGO–(BUSINESS WIRE)–The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation […]

Circulation Publishes Data Validating Vektor Medical’s Non-invasive Heart Mapping Technology Using Only 12-lead ECG

Study shows 97.3% accuracy in identifying arrhythmia source locations in nine atrial and ventricular arrhythmias and pacing types across all four heart chambers. September 07, 2022 08:34 AM Eastern Daylight Time SAN DIEGO–(BUSINESS WIRE)–Vektor Medical, the developer of the world’s first technology to rapidly map cardiac arrhythmias using only 12-lead […]

Boston Scientific Receives FDA Approval for Expanded Labeling of WATCHMAN FLX™ LAAC Device for Dual Anti-Platelet Therapy as Post-Procedural Medication Option

WATCHMAN FLX now the only LAAC technology in the United States that allows for either DAPT or OAC immediately following implantation MARLBOROUGH, Mass., Sept. 6, 2022 /PRNewswire/ — Boston Scientific Corporation ( NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the current-generation WATCHMAN FLX™ Left […]

AtriAN Medical Completes Enrollment of Second Study on Cardioneuroablation using PFA

This follow-up trial builds on AtriAN’s initial safety and feasibility study and aims to assess the efficacy of its cardioneuroablation treatment in patients with atrial fibrillation.  GALWAY, Ireland, Sept. 6, 2022 /PRNewswire/ — AtriAN Medical today announced that it has completed enrollment of a second study using its selective pulsed field ablation (PFA) […]

Biosense Webster Launches the OCTARAY™ Mapping Catheter with TRUEref™ Technology

The OCTARAY™ Mapping Catheter with TRUEref™ Technology provides physicians with the precise information needed for catheter ablation procedures that treat cardiac arrhythmias1,2† IRVINE, Calif., Sept. 6, 2022 /PRNewswire/ — Biosense Webster, Inc., part of Johnson & Johnson MedTech‡, today announced the release of the OCTARAY™ Mapping Catheter with TRUEref™ Technology powered by the […]

FDA-approved Investigator-initiated Pre-market Clinical Trial of LAmbre™ Plus LAA Closure System Obtained Medical Insurance Coverage in the US

SHENZHEN, China, Sept. 5, 2022 /PRNewswire/ — LifeTech Scientific Corporation (Stock Code: 1302.HK) is pleased to announce that on 30 August 2022, an FDA-approved investigator-initiated pre-market clinical trial of its proprietary LAmbre™ Plus Left Atrial Appendage (LAA) Closure System has obtained medical insurance coverage in the United States, meaning that all patient enrollment of […]

Sensifree Wins CE Certification for SentiCor-100® Continuous Non-Invasive Blood Pressure Monitor

KFAR SABA, Israel and SANTA CLARA, Calif., Aug. 31, 2022 /PRNewswire/ — Sensifree LTD, a world innovator in advanced hemodynamic monitoring (“Sensifree”), received CE certificate for SentiCor-100® in compliance with the new EU MDR. SentiCor-100® is the world’s first PPG based Continuous Non-Invasive Blood Pressure (cNIBP) monitoring device approved for hospital use. “This is an important landmark […]

BIOTRONIK LiveSupport Increases Efficiency for Remote Cardiac Clinics

LAKE OSWEGO, Ore., Aug. 31, 2022 /PRNewswire/ — BIOTRONIK’s LiveSupport feature has been successfully used to remotely support Cardiac Rhythm Management (CRM) clinics. This new technology enables BIOTRONIK representatives to provide programmer support from remote locations, allowing for faster support for clinics and addressing concerns around in-person contact brought on by the […]

Volta Medical’s AI based solution for patients in atrial fibrillation achieves robust validation in first peer-reviewed publication

Volta VX1 decision support software reproduces expert-physician electrogram (EGM) analysis that can assist physicians in the real-time identification of specific abnormal electrograms in a persistent atrial fibrillation (AF) population After a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after […]