Rhythm

ABBOTT’S HEARTMATE 3 HEART PUMP NOW FDA APPROVED FOR ADVANCED HEART FAILURE PATIENTS NOT ELIGIBLE FOR A HEART TRANSPLANT

ABBOTT PARK, Ill., Oct. 19, 2018 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not […]

Bardy Diagnostics™ awarded Innovative Technology Contract with Vizient, Inc. for the Carnation Ambulatory Monitor™

SEATTLE, Oct. 11, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it was awarded an Innovative Technology contract with Vizient, Inc. for the Carnation Ambulatory Monitor (“CAM™”), the world’s first P-wave centric™ ambulatory cardiac patch monitor and arrhythmia […]

Geneva Health Solutions Launches Geneva University

NEW YORK–(BUSINESS WIRE)–Geneva Health Solutions (GHS), the leading cloud-based technology platform and service for managing data from implantable cardiac devices, has formalized its internal training systems by launching Geneva University, a business unit within GHS. Geneva University will be focused on the continuous improvement of all clinical and administrative processes. “Implantable […]

Heart Center Dresden to Be First Commercial Clinical Site for Imricor

MINNEAPOLIS–(BUSINESS WIRE)–Imricor announced today that it signed its first commercialization contract for the Advantage-MR EP Recorder/Stimulator System and supporting Vision-MR devices1 with the Heart Center Dresden in Germany. This agreement places the Heart Center Dresden at the forefront of clinical advancement for MRI-guided cardiac ablations and establishes the hospital as a […]

Adagio Medical Completes Chronic Pre-Clinical Atrial Fibrillation Study Using Ultra-Low Temperature Cryoablation Technology

LAGUNA HILLS, Calif., Oct. 4, 2018 /PRNewswire/ — Adagio Medical, Inc., the developer of the iCLAS™ technology, the company’s ultra-low temperature intelligent continuous lesion ablation system for the treatment of cardiac arrhythmias, announces the successful completion of its chronic atrial fibrillation animal study, performed in collaboration with the LIRYC Research Institute of Bordeaux, […]

EPIX Therapeutics Announces Completion of DIAMOND-AF Paroxysmal Study and First Enrollment in DIAMOND-AF II Persistent Study

SANTA CLARA, Calif., Oct. 4, 2018 /PRNewswire/ — EPIX Therapeutics, Inc., a medical device company that designs and manufactures a catheter-based system for the treatment of patients with atrial fibrillation (AFIB), today announced achievement of the enrollment goal of the DIAMOND-AF study, a global FDA-approved IDE pivotal study to evaluate the DiamondTemp Ablation […]

Trial Results of Mesoblast Cell Therapy in End-Stage Heart Failure Selected as Late-Breaking Presentation at 2018 American Heart Association Scientific Sessions

NEW YORK and MELBOURNE, Australia, Oct. 02, 2018 (GLOBE NEWSWIRE) — Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that the 159-patient randomized placebo-controlled Phase 2b trial evaluating its allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in the treatment of end-stage heart failure patients implanted with a left ventricular assist device (LVAD) has […]

CathVision Receives ISO 13485:2016 Certification

COPENHAGEN, Denmark, October 2, 2018 /PRNewswire/ — CathVision ApS, an early stage medical device company developing an advanced cardiac electrophysiology recording system, CUBE, announced today that the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the […]

Adagio Medical Treats First Atrial Fibrillation Patients Using New One Shot+™ Cryoablation Catheter

LAGUNA HILLS, Calif., Oct. 1, 2018 /PRNewswire/ — Adagio Medical, Inc., the developer of the iCLAS™ technology, the company’s ultra-low temperature intelligent continuous lesion ablation system for the treatment of cardiac arrhythmias, announces that the first patients were successfully treated with its new One Shot+™ cryoablation catheter. The new catheter is aimed at […]

BIOSENSE WEBSTER ANNOUNCES FIRST PATIENTS ENROLLED IN POST-MARKET APPROVAL STUDY FOR ITS NOVEL TAG-INDEX GUIDED SOFTWARE

IRVINE, Calif., SEPTEMBER 26 – Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has received approval from the U.S. Food and Drug Administration (FDA) for its VISITAG SURPOINT External Processing Unit and enrollment has begun […]