WASHINGTON–(BUSINESS WIRE)–CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic solution for patients with suspected pulmonary hypertension. The FDA’s Breakthrough […]
Author: Ken Dropiewski
CARMAT Announces That It Has Received the Necessary Regulatory Approvals to Resume Aeson® Commercial Implants
DEKRA has provided notified body approval of all changes implemented by CARMAT PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of Aeson®, the world’s most advanced total artificial heart, designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced today that it has […]
V-Wave Completes Enrollment in the RELIEVE-HF Randomized Double-Blind Controlled Trial of Interatrial Shunting for Heart Failure
The RELIEVE-HF trial of the Ventura® Shunt System includes patients with reduced and preserved left ventricular function etiologies for heart failure CAESAREA, Israel, Oct. 24, 2022 /PRNewswire/ — V-Wave, announced today the completion of enrollment in RELIEVE-HF, a prospective, randomized, double-blinded, sham-controlled, multi-center pivotal clinical trial. The RELIEVE-HF study is assessing the safety […]
Cohere Health and Humana Expand Partnership to Further Improve Physician and Member Experiences
Technology will bundle and accelerate prior authorization for cardiovascular and surgical services BOSTON, Oct. 24, 2022 /PRNewswire/ — Today Cohere Health, a leader in intelligent utilization management (UM) technology, announced that Humana Inc. (NYSE: HUM) will expand its use of Cohere’s digital UM collaboration platform to enable seamless prior authorization for cardiovascular and surgical services. […]
Englewood Health Achieves Highest Possible Quality Rating for Valve Replacement Procedure
New Jersey’s only hospital to achieve a 3-star rating for transcatheter aortic valve replacement ENGLEWOOD, N.J., Oct. 24, 2022 /PRNewswire/ — Englewood Health has been recognized by The Society of Thoracic Surgeons with a 3-star rating—the highest possible quality rating—for transcatheter aortic valve replacement (TAVR). This mark of distinction reflects the accomplishments of the […]
Adagio Medical Announces Initiation and First Patient Enrollment in PARALELL Trial To Investigate Safety and Performance of CryoPulse™ Catheter System for Pulsed Field Ablation and Pulsed Field Cryoablation of Persistent Atrial Fibrillation
LAGUNA HILLS, Calif. , Oct. 24, 2022 /PRNewswire/ — Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced its first pulsed field cryoablation (PFCA) procedure performed using the Adagio CryoPulse™ catheter system as part of the PARALELL (Pulsed Field Ablation and Pulsed Field CRyoAbLation […]
Aziyo Biologics Appoints Seasoned Healthcare Executive, David Colpman, to Board of Directors
Industry veteran brings more than 25 years of healthcare business development and transaction experience SILVER SPRING, Md., Oct. 24, 2022 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO), a regenerative medicine company with a portfolio of commercial therapies, today announced the appointment of David Colpman to its Board of Directors […]
JenaValve Appoints Duane Pinto, MD, MPH, as Chief Medical Officer
IRVINE, Calif., Oct. 24, 2022 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced that Duane Pinto, MD, MPH, has been appointed as Chief Medical Officer. A leader in interventional cardiology, Dr. Pinto joins JenaValve following more than 20 years […]
BioSig Signs Master Research Agreement with Cleveland Clinic to Explore Expanded Applications for its Digital Signal Processing Technology
Medical Center of Excellence to leverage the Company’s PURE EP™ System to further its research and educational objectives as a leader in cardiac electrophysiology Clinical investigations conducted by Cleveland Clinic could expand clinical parameters of BioSig’s digital signal processing technology for arrhythmia care BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or […]
Philips’ Q3 performance impacted by operational and supply challenges; company is taking immediate actions to restore performance
Source: Royal Philips (Philips Press Release) Highlights Group sales amounted to EUR 4.3 billion, with a 5% comparable sales decline, in line with the update provided on October 12, 2022 Comparable order intake decreased 6% on the back of 47% growth in Q3 2021 Income from operations amounted to a loss […]
