Eko’s Heart Murmur Analysis Earns FDA Nod

Eko has earned U.S. Food and Drug Administration (FDA) clearance for its Eko Murmur Analysis software to detect and characterize murmurs in adults and children.
 
The smart stethoscope can identify and differentiate between innocent and structural heart murmurs potentially indicative of heart disease. By combining murmur analysis artificial intelligence (AI) with its digital stethoscope, the traditional stethoscope has been transformed into an objective, low-cost, scalable screening tool to spot structural heart disease in seconds.
 
“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,” Connor Landgraf, Eko’s co-founder and CEO told the press. “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.”
 
The EMAS algorithm, according to the FDA 510(k) summary, demonstrated 85.6% sensitivity and 84.4% specificity. In adults, the algorithm identified structural murmurs with 90.2% sensitivity and 90.6% specificity.
 
In comparison, traditional stethoscope use by general practitioners yielded 44% sensitivity and 69% specificity.
 
“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.”