DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital […]
Other News
Cardiost, Inc. Strengthens Scientific Advisory Board with Renowned Cardiovascular Experts, Advances Prototype Development with OEDIT Grant Support
Fort Collins, CO, Sept. 29, 2023 (GLOBE NEWSWIRE) — Fort Collins, CO – Colorado-based medical device start-up Cardiost, Inc., a graduate of Innosphere Ventures Accelerator program, has added key opinion leaders Dr. Daniel J. Goldstein, MD and Dr. Pedro R. Moreno, MD as part of their Scientific Advisory Board. Cardiost is currently designing an alpha prototype […]
Alio’s Remote Monitoring Platform Now Notifies Clinicians of Atypical Acoustic Data from Patients with Vascular Access
BROOMFIELD, Colo., Sept. 28, 2023 /PRNewswire/ — Today, Alio, Inc. announces the release of a new feature for its remote monitoring platform which notifies clinical care teams when there is a gap in typical acoustic data from a patient’s vascular access site. While the platform was FDA-cleared in March of this year to […]
AccuLine Announces Know-How License Agreement with Mayo Clinic to Advance Early Detection of Heart Attacks
PETAH-TIKVA, Israel, Sept. 28, 2023 /PRNewswire/ — AccuLine, a digital health startup company, has announced today a collaboration with Mayo Clinic through a know-how license agreement for the advancement of CORA, AccuLine’s novel solution designed for the early detection of coronary artery disease (CAD). As part of the agreement, Mayo Clinic will become a shareholder in […]
Clint and ACC Collaborate on Innovations to Advance Precision Health and Expand Access to Clinical Trials
Redwood City, California, Sept. 28, 2023 (GLOBE NEWSWIRE) — Clint, the clinical intelligence platform, is collaborating with the American College of Cardiology to advance precision health and expand access to clinical trials. This collaboration will accelerate time-to-market for novel therapies and support clinicians in identifying and closing care gaps for each individual patient […]
Nanox.AI’s HealthCCSng AI Solution Reveals ~60% of Patients in Study had Previously Undetected Risk of a Cardiovascular Event from Routine Chest CTs
NEVE ILAN, Israel, Sept. 28, 2023 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that HealthCCSng, an AI-powered solution created by Nanox’s deep-learning medical imaging analytics subsidiary, Nanox.AI, was used in a clinical study evaluating routine CT scans and found that […]
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 […]
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 […]
