CAIRO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced new eight-year data showing that patients receiving aortic surgical valves treated with its proprietary RESILIA tissue technology have significantly improved long-term outcomes compared to those receiving non-RESILIA tissue bioprosthetic valves. For more than 65 years, Edwards has been the leader in heart valve […]
Author: Ken Dropiewski
Adagio Medical Holdings, Inc. Receives FDA Breakthrough Device Designation for the vCLASTM Cryoablation System
Agency’s Breakthrough Device Designation Program Allows for Priority Review of Ablation Technology for Ventricular Tachycardia LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that it has received Breakthrough Device designation […]
FDA Clearance and First in Human Use for SoloPace™ Temporary Pacing System for TAVR
SAN FRANCISCO, April 17, 2025 /PRNewswire/ — Solo Pace Incorporated, an emerging medical technology company, announced both FDA Clearance and First-In-Human use of their SoloPace Control System for temporary pacing in Transcatheter Aortic Valve Replacement (TAVR) procedures. With…
Daxor Corporation to Showcase Innovative Blood Volume Analysis at MedAxiom Cardiovascular Transforum Spring 2025
WellStar Health System to Highlight New BVA-Driven Strategy That Significantly Reduces Kidney Injury Following LVAD Implantation Oak Ridge, TN, April 17, 2025 (GLOBE NEWSWIRE) — Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, announces today it will be exhibiting at the MedAxiom CV Transforum Spring’25 Conference being held at the Renaissance Orlando at SeaWorld in Orlando, FL from April 24-26, 2025. The Cardiovascular Transforum conference unites cardiovascular thought leaders from across the country to transform cardiovascular care together with leading industry innovators. Wellstar Health System’s Dr. Brian Howard will present findings showing how their Advanced Heart Failure program successfully reduced acute kidney injury rates following left ventricular assist device implantation through a multi-tiered approach centered on blood volume analysis (BVA). The presentation will share results from their retrospective cohort study and provide implementation strategies for attendees to replicate in their own programs. “We’re honored to have expert clinicians share their firsthand experience with BVA—why it matters, how to effectively integrate it into heart failure programs, and the meaningful impact it has on patient outcomes and quality of life,” said Michael Feldschuh, CEO and President of Daxor. BVA guided care has been shown in peer-reviewed studies to significantly improve multiple measures of patient outcomes including a reduction in 30-day mortality by 82%, 1-year mortality by 86%, 30-day readmissions by 56%, and results in a 55% reduction in length of stay when done on admission (P
AMT Medical Secures $25 Million in Series B Funding to Revolutionize Coronary Artery Bypass Surgery
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SonoVascular wins Angel Capital Association 2025 Luis Villalobos Award
CHAPEL HILL, N.C., April 16, 2025 /PRNewswire/ — SonoVascular, Inc., a clinical stage medical device company focused on bringing to market its SonoThrombectomy™ System, a safer and more effective treatment of venous thromboembolism (VTE), was awarded the Angel Capital Association’s 2025…
Terumo Health Outcomes Now Offers FDA-Cleared Medis QFR® 3.0 Software for Coronary Physiology Assessment in the US
– Innovative AI software supports hospital adoption of advanced tools to improve cath lab workflow and patient comfort – SOMERSET, N.J., April 16, 2025 /PRNewswire/ — Terumo Health Outcomes (THO), a division of Terumo Interventional Systems (TIS), today announced that Medis QFR 3.0, an…
LUMA Vision Receives FDA Clearance for VERAFEYE 2D/4D Cardiac Visualization Platform
Real-Time, 360-Degree Imaging Enhances Precision and Confidence in Cardiac Procedures DUBLIN, April 16, 2025 /PRNewswire/ — LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, today announced the FDA clearance of its VERAFEYE™ Visualization Platform. This…
Cellino Announces Partnership with Karis Bio to Develop First Nebula™-Powered Autologous iPSC Therapy for Cardiovascular Disease
CAMBRIDGE, Mass. & ATLANTA & SEOUL, South Korea–(BUSINESS WIRE)–Cellino, a biotechnology company pioneering autonomous biomanufacturing for personalized regenerative medicine, today announced its expansion into the Asia-Pacific region through a strategic collaboration with Karis Bio, a leading South Korean cell therapy biotech. The partnership aims to industrialize the world’s first clinical-stage […]
FDA grants clearance for HeartFocus, the transformative AI-powered cardiac imaging software
The milestone signals a new era of access for cardiac care, enabling any healthcare professional to perform diagnostic-grade echos anytime, anywhere. BORDEAUX, France, April 15, 2025 – DESKi today announced FDA clearance for HeartFocus, its AI-enabled heart exam software that empowers any healthcare professional, including novices, to perform clinical-quality […]