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FDA green lights Eko's heart murmur, a-fib algorithm

The new algorithms integrate with Eko's digital stethoscope.
By Laura Lovett
11:51 am

This morning digital cardiac health startup Eko announced that its atrial fibrillation and heart murmur detection algorithm landed a 510(k) FDA clearance. The new algorithms are designed to integrate with Eko’s stethoscope, which is already on the market, and be used by healthcare providers. 

The company said it plans to add more algorithms in the future. Next up will be an ECG-based algorithm that scored an FDA breakthrough status in December; however, it has not yet been cleared. 

This announcement comes months after Eko rolled out a second version of its CORE stethoscope that includes noise canceling capabilities and a sound amplifying feature. 


In the US, heart disease is the leading cause of death, according to the CDC. The agency estimates that heart disease costs the country $219 billion a year. 

Increasingly we are seeing innovators in the digital health space looking to tackle this issue with technology, with Eko’s latest tools specifically focusing on detection. In a small pediatric heart study published in Circulation, Eko’s heart murmur tool performed on par with cardiologists. 

“Two centuries after its invention, the stethoscope is still the front line tool to detect cardiovascular disease,” Dr. Patrick McCarthy, executive director of the Bluhm Cardiovascular Institute at Northwestern Medicine and member of Eko’s Scientific Advisory Board, said in a statement. “Eko’s development of artificial intelligence algorithms to help clinicians better interpret sounds, identify arrhythmias and detect heart murmurs during a physical exam is going to make a huge difference in our ability to care for patients.”


Founded in 2013, Eko has specialized in cardiac health and digital stehocopes. It got its first Its original Eko Core got the FDA greenlight in 2015 — the most recent version of the Eko Core was released in 2019.  The company has worked on other products as well. In 2018 Steth IO launch of its smartphone-based digital stethoscope, which is built directly into the protective case of a physician’s iPhone (models 6 and higher), allowing them to listen to and measure heart rates or lung sounds by running an app and holding the phone up to a patient’s chest.  

While Eko focuses on the provider space, consumer-focused products are increasingly adding cardio features as well. Most notable was the Apple Watch Series 4, which received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG. Since then Withings has unveiled its latest watch with ECG capabilities (though it is still pending FDA clearance).


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