WHITE PLAINS HOSPITAL

FDA Grants Coredio Breakthrough Designation for AI-Powered Heart Failure Monitoring Platform

- Coredio's Cardiac Performance Simulation Engine (CPSE) received FDA breakthrough device designation for AI-powered heart failure assessment using consumer wearables and standard blood pressure cuffs. - The platform creates a digital twin of patients' cardiovascular systems to monitor four key hemodynamic parameters comparable to cardiac catheterization without invasive procedures. - CPSE addresses the critical post-discharge period when approximately 30% of heart failure patients are readmitted within three months and mortality approaches 10%. - The software-only solution was also accepted into the FDA's Total Product Life Cycle Advisory Program, accelerating its path to 510(k) submission.