Eko Health Receives First FDA Clearance for Cardiac Foundation Model
Advanced AI model transforms cardiac exams with faster detection, fewer false positives, and proven accuracy for structural murmurs and atrial fibrillation.
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®.
“FDA clearance for EFAST represents a pivotal step in our mission to equip clinicians with tools that support earlier and more confident detection of cardiovascular disease,” said Connor Landgraf, CEO of Eko Health. “This achievement strengthens our ability to help patients receive the right care at the right time.”
“Our teams have combined expertise in AI, signal processing, and cardiovascular science to deliver an algorithm that is both clinically robust and highly practical,” said Kumar Iyer, Chief Product Officer at Eko Health. “EFAST reflects years of innovation and close collaboration with the medical community.”
The EFAST algorithm will be available to SENSORA® customers in a future software release.
About Eko Health
Eko Health is a pioneering AI early disease detection company advancing how healthcare professionals detect and monitor heart and lung disease with its portfolio of digital stethoscopes, ECG devices, patient and provider software, and AI-powered analysis. The FDA-cleared SENSORA® platform, with more than 650,000 devices sold to providers worldwide, helps clinicians detect earlier, manage treatment effectively, and give patients the best care possible. Eko Health is headquartered in Emeryville, California.
For more information about Eko Health, visit ekohealth.com.
Media contact
Sam Moore
sam.moore@ekohealth.com
MKT-0003998
