Eko receives FDA clearance for heart murmur analysis algorithm

Smart stethoscope firm Eko final week introduced it has acquired FDA 510(ok) clearance for an algorithm that detects and characterizes heart murmurs in grownup and pediatric sufferers.

Eko Murmur Analysis Software, which formally received the green light in late Juneis a machine studying algorithm that makes use of heart sounds, phonocardiograms and ECG alerts (when accessible) to detect murmurs and decide the kind, like harmless and structural heart murmurs.

According to the FDA’s database, this marks Eko’s fifth 510(ok). The firm has beforehand acquired clearance for an atrial fibrillation and heart murmur detection algorithm and for its Duo moveable ECG and stethoscope. Its sensible stethoscope first scored the FDA green light in 2015.

Eko is pitching the EMAS algorithm as a manner to assist clinicians discover valvular heart illness, supplied that affects about 2.5% of the US population and is extra frequent in older adults.

“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 cofounder and CEO of Eko, mentioned in a press 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 scored $65 million in Series C funding in 2020, and introduced a $30 million extension earlier this 12 months. According to Crunchbasethe corporate’s whole increase is greater than $125 million.

Another firm centered on utilizing AI to detect heart situations in Anumana, a three way partnership between EHR information firm nference and the Mayo Clinic. It just lately introduced a partnership with Novartis to develop AI instruments to detect cardiovascular illnesses.

Meanwhile Eko has labored with the Mayo Clinic to construct an algorithm to establish low ejection fraction, an indication of heart failure, which acquired FDA Breakthrough Device Designation and a brief Emergency Use Authorization through the COVID-19 pandemic.

Other corporations within the tech-enabled heart well being area embody Ultromics, maker of AI-supported cardiac imaging instruments, which raised $33 million final 12 months and private ECG maker AliveCor, which just lately launched a heart well being administration and training program for employers, well being plans and well being techniques.


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