Coronary/Structural Heart

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 […]

Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human

IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure […]

Pi-Cardia Successfully Completes Enrollment in Pivotal Study for ShortCut™

REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today the successful completion of its ShortCut™ Pivotal Study enrollment. ShortCut™ is the world’s first dedicated device designed to split the leaflets of pre-existing valves to enable safe Transcatheter […]

HeartSciences Signs Definitive Agreements with the Icahn School of Medicine at Mount Sinai to Commercialize Artificial Intelligence Cardiovascular Algorithms

Southlake, TX, Sept. 21, 2023 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an AI-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced it has executed definitive agreements with the Icahn School of Medicine […]