BOULDER, Colo.–(BUSINESS WIRE)–Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other […]
Other News
Attune Medical’s ensoETM™ Granted FDA De Novo Marketing Authorization to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting from Radiofrequency Cardiac Ablation Procedures
CHICAGO–(BUSINESS WIRE)–Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. “Our lab has published studies showing a 30 percent reduction in procedure time and a 14 percent […]
Forum Health Launches Groundbreaking AI Technology to Detect Signs of Heart Disease at an Earlier Stage
FLINT, Mich., Sept. 12, 2023 /PRNewswire/ — Forum Health Fond du Lac, a Forum Health national integrative and functional medicine network, has launched the Multifunction Cardiogram™ (MCG™) scan for early detection of heart disease and cardiac abnormalities. Learn more about the MCG™ scan. Unlike traditional methods that rely on symptom onset, the MCG™ scan […]
MedAlliance Announces Enrollment of over 1,660 Patients in Landmark SELUTION DeNovo Study
GENEVA, Sept. 14, 2023 /PRNewswire/ — MedAlliance has announced enrollment of over 1,660 patients in its ground-breaking SELUTION DeNovo coronary randomized study. Recruitment is now half way towards a planned 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon (SELUTION SLR), versus any limus drug-eluting stent (DES). […]
Protaryx Medical Welcomes David Mester as New CEO to Spearhead Advancements in Transseptal Access Technology
BALTIMORE–(BUSINESS WIRE)–Protaryx Medical, a pioneer in medical device innovation, today announced the appointment of David Mester, MBA as its new chief executive officer (CEO). With a career spanning over 33 years in the structural heart medical device industry, Mester brings a wealth of experience and expertise to guide Protaryx into […]
CorVista Health Announces FDA Clearance of the Novel CorVista System to Detect the Presence of Cardiac Disease
WASHINGTON–(BUSINESS WIRE)–CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the FDA clearance of the CorVista System® with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis. “CorVista Health’s innovative solution has the potential […]
FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options
PARIS & SAN JOSE, Calif.–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow System to help people with […]
Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma
DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical […]
Canon Medical introduces Alphenix Sky 12 HD interventional system with the new 12”×12” High-Definition (Hi-Def) Detector
Tustin California, Sept. 12, 2023 (GLOBE NEWSWIRE) — Tustin, CA, USA, 12th of September 2023 – Continuing its focus on providing clinicians with clarity and precision during interventional procedures, Canon Medical Systems Corporation is introducing this technology for the Alphenix Sky 12 HD interventional system with our proprietary high-resolution HD 76 Hi-Def […]
Shockwave Medical Appoints Nick West as Associate Chief Medical Officer
SANTA CLARA, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today that Nick West, MA, MD, FRCP, FESC, FACC, has joined the company in the role of Associate Chief […]
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