Eko secures heart murmur AI clearance for digital stethoscopes

Eko’s smart stethoscopes have been used by U.S. physicians to automatically detect signs of atrial fibrillation and heart murmurs since its first FDA clearance arrived in 2020. A new regulatory OK unveiled this week aims to make the devices even smarter.

The company’s latest clearance covers its artificial intelligence-powered Eko Murmur Analysis Software, or EMAS, which doesn’t just detect heart murmurs, but also identifies their timing and severity. The software was given the green light to help diagnose murmurs in patients of all ages—an upgrade from the digital stethoscope’s original software platform, which was cleared only for adult patients.

“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,” Patrick McCarthy, M.D., executive director of Northwestern Medicine’s Bluhm Cardiovascular Institute, said in a statement.

“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,” McCarthy said.

The EMAS technology combines a handful of machine learning AI algorithms to analyze the heart sound recordings and optional ECG data collected by Eko’s stethoscopes.

The algorithms first parse out the timing of a patient’s heartbeat to determine whether a murmur may be present. If one is detected, the AI distinguishes between whether it’s innocent or structural, then identifies whether the murmur occurs in the systole or diastole region of the heart cycle.

According to Eko, studies have proven that the EMAS algorithms can help doctors spot murmurs—an early sign of valvular heart disease—with sensitivity and specificity rates of around 85%. That accuracy increases in older patients, with both rates jumping to 90% when the AI is used to look for murmurs in people aged 18 and older.

The technology is indicated only as a diagnostic aid, rather than a definitive murmur detection tool—but it’s a much-needed one, as Eko cited data showing that when physicians use only standard stethoscopes to listen for murmurs, their sensitivity drops to 44% and specificity falls below 70%.

The regulatory win comes not long after Eko launched a new version of its smartphone app to bring its heart sound-analyzing AI to healthcare providers at no cost, compared to a previous subscription model that began at $50 per month.

The new plan allows doctors to access the company’s standard afib and heart murmur diagnostic aids on their existing mobile devices. The AI works only alongside Eko’s stethoscope technology, which includes its Core and Duo devices—the latter of which can perform ECG readings—and a digital attachment that can turn any stethoscope into a smart one.