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FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

First and only machine learning algorithm to assist healthcare professionals in identifying structural heart murmurs using a smart stethoscope

Eko, a digital health company advancing heart and lung disease detection, announced that the U.S. Food and Drug Administration (FDA) has cleared its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults and pediatric patients. The next generation of Eko’s murmur detection capabilities grants Eko the first and only smart stethoscope on the market that can identify and differentiate, between innocent and structural, heart murmurs indicative of valvular heart disease.

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Valvular heart disease is a life-threatening condition diagnosed in more than 8 million Americans1 and is often first identified with a stethoscope. While early detection is critical, millions of patients are expected to be undiagnosed, with as much as 57% of clinically significant valvular heart disease missed.2 By combining murmur analysis AI with its digital stethoscopes, Eko has transformed the traditional stethoscope into an objective, low-cost, and scalable screening tool that can identify significant structural heart disease in seconds on the front lines of care.

“This latest FDA clearance is another way in which Eko is improving access to better heart health through clinically-validated algorithms and best-in-class medical devices,” said Connor Landgraf, Co-founder & CEO of Eko. “By making heart disease screening algorithms and digital stethoscopes accessible in exam rooms around the country, we are moving towards a future in which more objective and consistent valvular heart disease screening can become the standard of care.”

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The EMAS algorithm greatly improves the performance of healthcare professionals to accurately and consistently identify valvular heart disease, with an overall sensitivity of 85.6% and specificity of 84.4%.3 Further analysis showed that among adults 18 years and older, the EMAS algorithm identified structural murmurs with a sensitivity of 90.2% and specificity of 90.6%.4 When using traditional stethoscopes to detect significant valvular heart disease, general practitioners (GPs) were found to have a sensitivity of 44% and specificity of 69%.5

“Combining pathologic murmur detection with the stethoscope, a tool already deeply embedded in the practice of medicine, will allow for more accurate and efficient screening of heart valve disease in the community,” said Dr. Patrick McCarthy, Executive Director of the Bluhm Cardiovascular Institute at Northwestern Medicine. “Eko’s platform will help uncover early valvular heart disease in millions of people worldwide who may otherwise be missed, and make a significant impact on our ability to treat patients with life-saving interventions.”

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