AI Heart Failure Software Gains FDA Breakthrough Status

Coredio's groundbreaking haemodynamic heart failure assessment software, the cardiac performance simulation engine (CPSE), has been granted breakthrough device designation by the US Food and Drug Administration (FDA). This digital health solution is designed to aid clinicians in monitoring heart failure patients after hospital discharge, a critical and vulnerable period. The CPSE utilizes artificial intelligence to create a 'digital twin' of a patient's cardiovascular system. This allows for on-demand assessments of haemodynamic status using wearables and standard blood pressure cuffs, providing insights comparable to cardiac catheterization.

Beyond breakthrough designation, the CPSE has also been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP), a voluntary initiative aimed at expediting patient access to innovative medical devices. Heart failure remains a leading cause of global hospital admissions, affecting millions with significant projected increases in prevalence and costs. Coredio's AI software represents a significant advancement in managing this condition, potentially improving outcomes for patients during their most vulnerable recovery phase.