NEW HOPE, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration (the “FDA”) granted investigational device exemption (“IDE”) approval with conditions […]
Coronary/Structural Heart
VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally
HANGZHOU, China, Aug. 6, 2023 /PRNewswire/ — Recently, Venus Medtech (Hangzhou) Inc. (“Venus Medtech”), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption (IDE) full approval for its in-house developed VenusP-Valve from the U.S. Food and Drug Administration (FDA). VenusP-Valve, thus, has become the […]
Lilly’s Retevmo® (selpercatinib) is the First Targeted Therapy to Demonstrate Superior Progression-Free Survival Compared to a PD-1 Inhibitor Plus Chemotherapy for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
INDIANAPOLIS, Aug. 4, 2023 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-431 study evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed – with or without pembrolizumab – as an initial treatment for patients with rearranged during transfection (RET) fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC). The study met […]
Results from XyloCor Therapeutics’ Phase 1 Portion of EXACT Trial of XC001 for Cardiovascular Disease Published in Circulation: Cardiovascular Interventions
WAYNE, Pa.–(BUSINESS WIRE)–XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, announced today that Circulation: Cardiovascular Interventions has published results from the Phase 1 portion of its Phase 1/2 clinical trial (EXACT) of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. The findings […]
Cardio Diagnostics Holdings, Inc Announces Expansion of IP Portfolio in Australia with Notice of Allowance of Patent Application
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, today announced that Australia’s Patent Office has issued a Notice of Allowance to the University of Iowa Research Foundation (“UIRF”) for Australian Patent Application No. 2017277666, titled “Compositions and Methods for Detecting Predisposition to Cardiovascular […]
Alucent Biomedical Wins FDA Approval for U.S. Clinical Study
SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology. “AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and […]
Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+™ Hemostatic Device Usage in Cardiac Surgical Procedures
WAYNE, Pa., Aug. 01, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+™ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a […]
Cadrenal Therapeutics Expands Focus for Tecarfarin to Patients with Implanted Medical Devices for Heart Diseases
PONTE VEDRA, Fla., Aug. 1, 2023 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company focused on developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced that the Company is expanding its focus for tecarfarin to patients with implanted medical devices for heart diseases […]
Peijia Medical Announces First Chinese Patient Implanted with TaurusTrio™ Transcatheter Aortic Valve Replacement System
SUZHOU, China, Aug. 1, 2023 /PRNewswire/ — Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, announced on July 31, 2023 that the first Chinese patient of the multi-center registration clinical trial for TaurusTrio™ Transcatheter Aortic Valve Replacement (TAVR) system has been enrolled. TaurusTrio™ is […]
First Patients Outside of U.S. Treated with TRIA Polymer Surgical Mitral Heart Valve
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced that the first 30 patients have been treated outside of the U.S., in the Indian clinical trial of the TRIA™ surgical mitral heart valve. The TRIA mitral valve is designed specifically to accommodate […]



