Egnite, Pathway Labs and Stamford Health are testing whether FDA-cleared ECG artificial intelligence can improve identification and follow-up of patients with possible structural heart disease. The pilot combines automated screening with longitudinal clinical records and will measure whether flagged patients actually receive further evaluation.
Laplace Interventional has treated the first three patients in its FDA-authorised TRIUMPH pivotal trial, moving its investigational tricuspid valve into a randomised comparison with commercial replacement technology. With approximately 400 patients planned for the main study, the company must demonstrate meaningful safety and effectiveness in an increasingly competitive structural heart market.
CMS has modernized Medicare coverage for transcatheter aortic valve replacement, ending evidence-development requirements for symptomatic severe aortic stenosis while creating a pathway for certain asymptomatic patients.
Valve durability is becoming a lifetime-care question. Edwards Lifesciences’ 10-year RESILIA data raise the stakes for heart teams.
Find out how transcatheter tricuspid valve replacement is reshaping treatment options for severe regurgitation and what clinicians are watching next.
Edwards Lifesciences’ SAPIEN M3 becomes the first FDA-approved transseptal mitral valve replacement system. Explore how it reshapes TMVR in 2026.