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FDA Clears Groundbreaking AI for Enhanced Heart Failure Detection in Routine Health Assessments

Wednesday, April 03, 2024

Eko Health, a leader in the application of artificial intelligence (AI) for early heart and lung disease detection, has received FDA clearance for its Low EF detection AI. This breakthrough enables U.S. healthcare providers to quickly identify Low EF, a key sign of heart failure, within 15 seconds using an Eko stethoscope during regular check-ups. This development represents a significant advancement in medical technology and signals a new chapter in cardiovascular disease detection.

In the United States, over 6 million people are affected by heart failure, with half experiencing heart failure with reduced ejection fraction (HFrEF), where the heart struggles to pump blood effectively. Traditional tools like echocardiography, while effective, are often impractical in primary care due to cost and complexity. This leads to undiagnosed cases until symptoms worsen, resulting in worse outcomes and higher healthcare costs.

Eko's Low EF AI disrupts this pattern by seamlessly integrating low ejection fraction detection into routine stethoscope exams, empowering frontline healthcare providers. Detecting hidden heart conditions early with a familiar tool like the stethoscope can prevent hospitalizations and complications. This AI will be integrated into Eko's SENSORA Cardiac Early Detection Platform, which already includes FDA-cleared algorithms for identifying AFib and heart murmurs, often indicating valve issues. Identifying Low EF in primary care exams with SENSORA can expedite access to life-saving treatments through referral to cardiology departments for further evaluation.

This innovation, turning a traditional medical tool into an AI-powered early detection system for heart failure, promises to enhance care accessibility and reduce costs. Collaborating with Mayo Clinic on this project has been a privilege.


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