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 […]
Other News
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 […]
Microbot Medical Engages CRO to Support its Upcoming U.S. Pivotal Clinical Trial
BRAINTREE, Mass., Sept. 27, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, announced today its partnership with a Contract Research Organization (CRO) in the U.S. This is an additional step in the preparations to the commencement […]
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, […]
The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas
TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ — Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a Breakthrough Technology, was cleared based on […]
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 […]
Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer
CAMBRIDGE, Mass., Sept. 27, 2023 /PRNewswire/ — Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, announced that Jon Hunt, PhD., has joined the company as its new Chief Commercial Officer (CCO), North America. In this role, Hunt will focus on business and sales strategies for the U.S. market to maximize […]
HeartBeam Appoints Richa Gujarati and Pooja Chatterjee to Senior Management Team
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram (VECG) platform for patient use at home, allowing for the creation of rich data for AI, has appointed Richa Gujarati as Senior Vice President, Product, and Pooja Chatterjee as […]
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 […]



