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Eko Health Gains FDA Clearance For Cardiology Algorithm That Can Detect Heart Failure in 15 Seconds

Eko Health received FDA clearance this week for a new AI-powered tool that aids in the early detection of low ejection fraction, a key indicator of heart failure. 

About 6.2 million Americans battle heart failure, with many of them experiencing low ejection fraction, a condition that occurs when the heart muscle pumps out less blood than normal during each contraction. 

Conventional methods for detecting reduced ejection fraction, such as echocardiography, are often unavailable in primary care settings because they are expensive and necessitate specialized training. Unfortunately, this means that many heart failure patients go undiagnosed until their symptoms get so bad that they need to visit a specialist of the emergency room.

“For many patients with heart failure, it takes a very long time for them to get a diagnosis. The symptoms early on in heart failure are pretty challenging for clinicians to identify,” Eko CEO Connor Landgraf said in an interview. “There is a staggeringly large number of these patients — something between 25% and upwards of 50% — who don’t get diagnosed until they have a hospitalization or a really bad acute event.”

Landgraf’s company, founded in 2013, seeks to help clinicians move away from this reactive model of disease detection. It is best known for its digital stethoscopes and AI platform.

Eko’s digital stethoscopes have been on the market for nearly a decade, and “about half a million” clinicians use them, Landgraf said. The company’s AI platform, released last year, uses machine learning algorithms to search through a large database of heart sounds and determine whether the sounds that a primary care provider hears through their stethoscope are normal or abnormal.

The company’s newly cleared AI tool gives providers using an Eko stethoscope the ability to detect low ejection fraction in just 15 seconds during a routine exam, Landgraf explained.

“We’re really excited that this can be part of an emergency department, urgent care or primary care exam — and that it can help identify which patients have the signs of disease and help them get quickly referred on to the right specialist,” he stated.

The tool was developed in collaboration with Mayo Clinic, Landgraf added. Eko trained its model on Mayo Clinic’s dataset of electrocardiograms (ECGs) and collaborated with the health system’s cardiologists on the tool’s design, he noted.

Landgraf also stated that Eko’s low ejection fraction detection tool is “the first of its kind.” 

Anumana sells an algorithm to detect reduced ejection fraction using 12-lead ECGs — but Eko’s tool is embedded into its digital stethoscopes. This means that Eko is the first company to build a low ejection fraction detection AI tool that is highly accessible for frontline clinicians, he declared.

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