Eko announced today that it received FDA clearance for its Eko Murmur Analysis Software (EMAS) for adult and pediatric patients.
The next generation of Eko’s murmur detection capabilities, EMAS represents 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.
According to a news release, Eko has transformed the traditional stethoscope into an objective, low-cost and scalable screening tool that can identify significant structural heart disease within seconds on the front lines of care. The company has collaborated in with 3M to connect its software and artificial intelligence algorithms and help clinicians use 3M’s stethoscope to better interpret sounds and detect heart murmurs, too.
“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,” Eko co-founder and CEO Connor Landgraf said in a news release. “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.”
Eko said its EMAS algorithm greatly improves the performance of healthcare professionals in accurately and consistently identifying valvular heart disease, producing an overall sensitivity of 85.6% and specificity of 84.4%.
Further analysis has demonstrated that, in adults 18 years of age and older, the EMAS algorithm identified structural murmurs with a sensitivity of 90.2% and specificity of 90.6%. Traditional stethoscopes used to detect valvular heart disease have shown to have a sensitivity of 44% and specificity of 69%, the company said.
“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,” added 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.”