Coronary/Structural Heart

Toku Obtains CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye

SAN DIEGO–(BUSINESS WIRE)–Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced today that it has obtained CE and UKCA Marks for its patented CLAiR technology. This significant milestone underscores Toku’s commitment to maintaining the highest standards of quality and safety and allows access to […]

Edwards’ EVOQUE Valve Replacement System First Transcatheter Therapy to Earn FDA Approval for Tricuspid Valve

IRVINE, Calif.–(BUSINESS WIRE)– Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR). The EVOQUE system is indicated for the improvement of health status in patients […]

SoniVie announces enrollment completion in the REDUCED-1 pilot study with TIVUS™ Ultra-Sound Renal Denervation

SoniVie announces enrollment completion in the REDUCED-1 pilot study TEL AVIV, Israel, Jan. 31, 2024 /PRNewswire/ — SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUSTM) System to treat a variety of hypertensive disorders, announced…

Genomics plc publishes clinical trial results demonstrating successful integration and clinical utility of integrated risk scores combining polygenic and clinical risk of cardiovascular disease in NHS primary care

Published in the European Journal of Preventive Cardiology, the paper demonstrates that polygenic risk score information can be successfully integrated into current general practitioner (GP) clinical practice for the prevention of cardiovascular disease The paper also demonstrates that…

New Philips Mini TEE ultrasound transducer helps improve cardiac care for more patients

January 31, 2023 Latest innovation has the potential to reduce anesthesia during minimally invasive procedures [1] As a pioneer and leading innovator in cardiac ultrasound, Philips has developed the smaller X11- 4t Mini 3D TEE transducer to serve more patients with this valuable imaging tool, from pediatric patients to older […]

Avenacy Announces Launch of Bivalirudin for Injection in the U.S. Market

January 29, 2024 08:00 AM Eastern Standard Time SCHAUMBURG, Ill.–(BUSINESS WIRE)–Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Bivalirudin for Injection in the United States as a therapeutic equivalent generic for Angiomax® for Injection (bivalirudin) approved by the U.S. Food and Drug […]

Rudolf Riester GmbH Announces Global Market Launch of Telemedicine Solution, Showcases ri-sonic® E-Stethoscope + eMurmur® AI Integration for Heart Murmur Detection at Arab Health 2024

JUNGINGEN, Germany–(BUSINESS WIRE)–Rudolf Riester GmbH, a global leader in medical technology, proudly announces the full market launch of its comprehensive Telemedicine offering. Already in active use across Europe, the Middle East, and Africa, the solution from the trusted Riester brand delivers industry-leading quality and versatility through integration of a broad range of […]

Cytokinetics Presents New Data at CMR 2024 From FOREST-HCM, the Open Label Extension Clinical Trial of Aficamten

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM). In many patients with […]

CroíValve Announces FDA IDE Approval and Initiation of its Early Feasibility Study

DUBLIN–(BUSINESS WIRE)–CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study (EFS) for the DUO™ Tricuspid Coaptation Valve System, following FDA IDE and CMS approval. The TANDEM II trial is a prospective, multi-center, non-randomized single-arm study […]