FDA clear Eko Health Low Ejection Fraction AI Algorithm


In the world of electronic stethoscopes, EKO is posing as one of the most innovative companies. Digital cardiac and lung disease health startup Eko Health announced it received FDA 510(k) clearance for its AI-enabled cardiac tool that helps with the early detection of low ejection fraction, a key indicator of heart failure. 

Eko Low Ejection Fraction Tool (ELEFT), which officially received the green light from the FDA in March, is an AI-enabled tool that allows providers to detect low ejection fraction in 15 seconds during a routine exam using an Eko stethoscope. 

ELEFT will be added to Eko’s SENSORA Cardiac Early Detection Platform, which already contains several FDA-cleared algorithms for identifying AFib and structural heart murmurs. 

Eko is pitching the ELEFT as a way to help clinicians detect patients with heart failure during routine physical examinations. This condition affects more than 6.2 million adults in the U.S.

According to Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, “The ability to identify a hidden, potentially life-threatening heart condition using a tool that primary care and clinicians are familiar with — the stethoscope — can help us prevent hospitalizations and adverse events.” Mr. Connor Landgraf, co-founder and CEO of Eko Health, added, “With Eko’s Low EF AI, we’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients at a fraction of the time and cost of echocardiography. It’s been a privilege to work alongside Mayo Clinic in this groundbreaking endeavor.”

Eko scored $65 million in Series C funding in 2020 and announced a $30 million extension in 2022. The company has received numerous 510(k) certificates, including for its Eko Murmur Analysis Software, which employs an algorithm to detect and characterize heart murmurs in adult and pediatric patients. It previously received clearance for an algorithm for detecting atrial fibrillation, heart murmurs, and its Duo portable ECG and stethoscope. 


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