Coronary/Structural Heart

PercAssist Announces First Patient Treated in EUREKA Study of PSCA System for Hemodynamic Support in Chronic Heart Failure

SANTA CLARA, Calif.–(BUSINESS WIRE)–PercAssist, Inc., a medical device company developing innovative technology for a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, today announced the successful completion of its first patient in the EUREKA First-in-Human clinical study. “This milestone marks the beginning of our efforts […]

Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for sotatercept, Merck’s novel investigational activin signaling inhibitor, for the treatment of adult patients […]

Patient with Second Historic Pig Heart Transplant Treated with Novel Investigational Antibody Therapy Produced at Berkshire Sterile Manufacturing

Lee, MA, Sept. 27, 2023 (GLOBE NEWSWIRE) — A historic transplant of a genetically modified pig heart has been successfully performed on a 20-year Navy veteran and married father of two suffering from end-stage cardiovascular disease. The surgery, which took place on September 20, was the patient’s last chance at […]

EnCompass receives FDA conditional IDE approval to commence a US pilot study of its F2 cerebral embolic protection (CEP) system in patients undergoing transcatheter aortic valve replacement (TAVR)

CARSON CITY, Nev., Sept. 27, 2023 /PRNewswire/ — EnCompass Technologies, Inc., a privately held medical device company focused on protecting patients from brain injury during cardiovascular procedures, announced the US Food and Drug Administration (FDA) officially granted conditional Investigational Device Exemption (IDE) approval for its F2 cerebral embolic protection system on Friday, September 22, […]

Zeus Launches Next-Generation Tubing for Bioresorbable Vascular Scaffolds

ORANGEBURG, S.C., Sept. 27, 2023 /PRNewswire/ — Zeus, a global leader in advanced polymer solutions, announced today that it has developed Absorv™ XSE oriented tubing, the newest member of the company’s family of bioabsorbable products. Available in a variety of resins and expanded size ranges, Absorv XSE provides a highly customizable platform […]

SHL Telemedicine’s SmartHeart® Technology Shows Remarkable Effects in Mayo Clinic and Imperial College London Trials

TEL AVIV, Israel & ZURICH & NEW YORK–(BUSINESS WIRE)–SHL Telemedicine Ltd. (NASDAQ: SHLT, SIX: SHLTN;) (“SHL” or the “Company”), a leading provider and developer of advanced personal telemedicine solutions, is pleased to announce the initial results from the Mayo Clinic HELP-MI and the Imperial College London TELE-ACS trials, presented at […]

Ultragenyx Launches Evkeeza® (evinacumab for injection) in Canada for the Treatment of Homozygous Familial Hypercholesterolemia (HoFH)

TORONTO, Sept. 25, 2023 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare genetic diseases, today announced the approval of Evkeeza® (evinacumab) in Canada. Evkeeza® was approved by Health Canada as an adjunct to diet and other […]

Cardiosense Begins Enrollment in Nationwide Heart Failure Study

CHICAGO, Sept. 26, 2023 /PRNewswire/ — Cardiosense, a digital health company developing a non-invasive monitoring platform for the early detection of heart disease, recently started enrolling patients in SEISMIC-HF I, its nationwide clinical study to refine and validate algorithms to assess intracardiac filling pressure, an early physiological marker for acute heart failure […]

Viz.ai Announces Expansion into Outpatient Ambulatory Centers to Accelerate Clinical Trial Recruitment in Heart Failure

SAN FRANCISCO, CA – September 26, 2023 – Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced the expansion into outpatient ambulatory centers to accelerate clinical trial recruitment. Amavita Heart and Vascular Health™, with facilities spanning four locations in Miami-Dade County, has taken a pioneering step by […]

Valo Health and Novo Nordisk to collaborate to discover and develop novel treatments for cardiometabolic diseases using human data and artificial intelligence

Bagsværd, Denmark and Boston, Massachusetts, US, 25 September 2023 – Novo Nordisk A/S and Valo Health, Inc. today announced they have entered into an agreement to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). The collaboration between the two organizations will leverage the capabilities […]