Coronary/Structural Heart

Roivios Secures FDA Breakthrough Device Designation for JuxtaFlow® RAD, Showcases Pioneering Data at Society of Cardiovascular Anesthesiologists Annual Meeting

NASSAU, Bahamas, April 26, 2024 /PRNewswire/ — Roivios, a pioneering clinical-stage medical device company dedicated to transforming kidney health, is thrilled to announce it has been awarded the prestigious Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)…

BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort

SUNNYVALE, Calif., April 25, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced completion of enrollment and collection of the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in […]

ACTICOR BIOTECH: Topline Results of ACTISAVE Phase 2/3 Study in Stroke Treatment

PARIS–(BUSINESS WIRE)–Regulatory News: “ACTISAVE Clinical Trial: Efficacy and Safety of Glenzocimab on Top of Thrombolysis with or without Mechanical Thrombectomy” Post this ACTICOR BIOTECH (FR0014005OJ5 – ALACT) (Paris:ALACT), a clinical-stage biotechnology company focused on the development of glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, today announced the […]

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

Citizen Petition Spotlights Risks for Patients on Drug Proven to Have No Benefit in Improving Cardiovascular Outcomes and Need for Urgent Regulatory Action to Protect Patients Citizen Petition Spotlights Risks for Patients on Drug Proven to Have No Benefit in Improving Cardiovascular Outcomes and Need for Urgent Regulatory Action to Protect Patients

ATACOR MEDICAL CLOSES $28M SERIES C FINANCING TO DELIVER NEXT GENERATION EXTRAVASCULAR ICD AND PACING OPTIONS FOR CARDIAC RHYTHM MANAGEMENT

Funding Supports Regulatory Submissions and Clinical Milestones for Proprietary Extravascular (EV) Pacing & Implantable Cardioverter Defibrillator (ICD) Lead Systems SAN CLEMENTE, Calif., April 24, 2024 /PRNewswire/ — AtaCor Medical Inc., a privately-held medical device company…

Exo® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure

April 23, 2024 08:30 AM Eastern Daylight Time SANTA CLARA, Calif.–(BUSINESS WIRE)–Exo® (pronounced “echo”), a medical imaging software and devices company, today announced its FDA-cleared cardiac and lung artificial intelligence (AI) applications are now available on Exo Iris™, Exo’s high-performance handheld ultrasound device. “Exo’s AI is simple to use, reproducible and objective, and will […]

Cedar Gate’s Heart Disease & Heart Failure Predictive AI Models Could Save $1.4 Billion with Early Intervention

April 23, 2024 09:00 AM Eastern Daylight Time GREENWICH, Conn.–(BUSINESS WIRE)–Cedar Gate Technologies (Cedar Gate) announced that an analysis of their national Healthcare Benchmark Database, encompassing nearly 13 million member lives, revealed a potential savings opportunity of approximately $1.4 billion. Machine learning models within Cedar Gate’s platform can identify, with a […]

Recor Medical Announces First Cases of Paradise Ultrasound Renal Denervation Therapy in the United Arab Emirates

Palo Alto, CA, April 18, 2024 (GLOBE NEWSWIRE) — Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), announce the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension in the United Arab Emirates (UAE). Three cases were […]

Karoo Health Launches Proprietary Technology Platform Kohere.ai to Supercharge Its Cardiac Value-based Care Model

AI-enriched platform transforms disparate data into actionable insights for care providers and partners, boosts patient engagement and access to care for improved outcomes at lower cost ALBUQUERQUE, N.M., April 18, 2024 /PRNewswire/ — Karoo Health, the only operational provider of…