Eko Health Receives First FDA Clearance for Cardiac Foundation Model
Eko Health, a leader in AI-powered cardiac and pulmonary detection, announced today that the U.S. Food and Drug Administration has cleared its new EFAST algorithm for use within the SENSORA® platform. EFAST is the first FDA-cleared foundation model for cardiovascular AI, and is indicated to detect structural heart murmurs and atrial fibrillation with greater specificity and faster exam times while maintaining exceptional accuracy.
Trained as a cardiac foundation model on more than four million de-identified heart sound and ECG recordings gathered across diverse care settings, EFAST first learns a general representation of cardiac acoustics and ECG then adapts that knowledge to specific clinical tasks through supervised fine-tuning and calibration. This approach supports higher specificity for structural murmur detection while preserving the strong sensitivity achieved by Eko’s prior model and enabling faster five-second auscultation per site. It is engineered for practical use at the point of care and for future expansion of capabilities within SENSORA®.
