Eka Health & Mayo Clinic’s AI Stethoscope Gets FDA Clearance

The project is a collaborative effort between Mayo Clinic researchers and the healthtech startup Eko Health.

In a groundbreaking development, an AI-enabled stethoscope has secured FDA clearance for its cutting-edge algorithm designed to predict heart failure.

The project is a collaborative effort between Mayo Clinic researchers and the healthtech startup Eko Health. While Mayo Clinic contributed the algorithm, Eko Health designed the hardware.

The newly approved algorithm, embedded within a digital stethoscope, aims to empower primary care physicians to identify heart failure swiftly and non-invasively.

Sharing thoughts, Dr Paul Friedman, chairperson, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, said, "The ability to identify a hidden, potentially life-threatening heart condition using a tool that primary care and subspecialist clinicians are familiar with – the stethoscope – can help us prevent hospitalizations and adverse events.’’

How Does it Work?

Eko’s stethoscope, equipped with an advanced AI algorithm developed by researchers from Mayo Clinic, detects Low EF, a key heart failure indicator, in 15 seconds during routine physical exams.

This algorithm has been fine-tuned to predict heart failure based on acoustic signals captured during auscultation. By analyzing heart sounds it detects subtle abnormalities indicative of heart failure.

Moreover, Eko's Low EF AI disrupts this status quo by embedding rapid and accessible low ejection fraction detection into a stethoscope exam on the front lines of care.

Reports suggest that the Low EF AI will be added to Eko's SENSORA Cardiac Early Detection Platform, the latest advancement to the platform which already features FDA-cleared algorithms to identify AFib and structural heart murmurs, often an indicator of valvular heart disease.

When Low EF is detected in a primary care exam with SENSORA, access to life-extending treatment can be expedited with a referral to the cardiology department for thorough diagnostic testing and treatment evaluation.

Further, this digital stethoscope can be used in urban and remote locations, to help address care in underserved areas.

Reportedly, heart failure affects approximately 6.5 million Americans, rendering their hearts incapable of pumping blood effectively.

Traditionally, clinicians relied on echocardiograms to visualize this condition. However, these tests come with a hefty price tag.

As a result, many heart failure cases go undiagnosed until symptoms force a specialist or emergency hospital visit, leading to worse patient outcomes and exacerbated healthcare costs.

Talking about the technology, Connor Landgraf, cofounder & CEO of Eko Health, said, "The stethoscope, the most recognizable symbol of healthcare, touches the lives of an estimated one billion people around the globe every year."

He further noted that AI-powered heart failure early detection tools can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography.

Founded in 2013 by Connor Landgraf, Tyler Crouch, and Jason Bellet, Eko Health provides healthcare professionals with cutting-edge digital tools, allowing them to listen to and interpret patients’ heart and lung sounds more accurately.

By leveraging technology, Eko Health enhances diagnostic capabilities, improves treatment management, and ultimately contributes to better patient care.

Mayo Clinic, on the other hand, was founded in 1864 by William Worrall Mayo. It is a nonprofit American academic medical center. Mayo Clinic’s mission revolves around integrated health care, education, and research.