The AI-enhanced digital stethoscope enables healthcare providers to detect low ejection fraction, a key indicator of heart failure, within 15 seconds during a standard physical exam.


CI’s 3 Key Takeaways:

  • The US Food and Drug Administration has cleared Eko Health’s Low Ejection Fraction AI, which allows healthcare providers to detect a key heart failure indicator in 15 seconds using an Eko stethoscope during routine exams.
  • This technology was developed in collaboration with Mayo Clinic and is designed to improve heart failure detection in primary care settings, where traditional tools like echocardiography may not be available.
  • Eko’s AI was trained on over 100,000 electrocardiograms and echocardiogram pairs and independently validated by Imperial College London, demonstrating its ability to accurately identify patients with low ejection fraction.

The US Food and Drug Administration (FDA) has cleared Eko Health’s Low Ejection Fraction (Low EF) AI which allows for more accurate assessment of possible heart failure in at-risk patients during a standard physical exam.

With the clearance, US healthcare providers can now detect Low EF, a key heart failure indicator, in 15 seconds using an Eko stethoscope during a routine physical examination. 

Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam.

Enhancing Primary Care with AI

In the US, more than 6 million people battle heart failure, with half of them experiencing heart failure with reduced ejection fraction (HFrEF)—a condition marked by the heart’s inability to pump blood effectively. Traditional heart failure detection tools, such as echocardiography, are often unavailable in primary care settings as they are costly, require specialized training, and add significant time. 

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. Eko’s Low EF AI embeds rapid and accessible low ejection fraction detection into a stethoscope exam.

“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,” says Paul Friedman, MD, chair of the Department of Cardiovascular Medicine at Mayo Clinic, in a release. “Importantly, since a stethoscope is small and portable, this technology can be used in urban and remote locations, and hopefully help address care in underserved areas.”

Advancing Heart Health

The Low EF AI will be added to Eko’s SENSORA Cardiac Early Detection Platform, the latest addition to the platform which already features FDA-cleared algorithms to identify atrial fibrillation 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.

Photo 155539031 | Artificial Intelligence Heart © Leowolfert | Dreamstime.com

“The stethoscope, the most recognizable symbol of healthcare, touches the lives of an estimated 1 billion people around the globe every year,” says Connor Landgraf, co-founder and CEO of Eko Health, in a release. “With Eko’s Low EF AI, we’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography. It’s been a privilege to work alongside Mayo Clinic in this groundbreaking endeavor.”

According to a release from Eko Health, clinical development and validation highlights include:

  • Robust AI training and validation: Eko’s Low EF AI was trained on a proprietary dataset of over 100,000 electrocardiograms and echocardiogram pairs from unique patients and was clinically validated in a multi-site, prospective clinical study of 3,456 patients, achieving an area under the receiver operating characteristic (AUROC) of 0.835 for detection of left ventricular ejection fraction (LVEF) <40%, 74.7% sensitivity and 77.5% specificity, demonstrating a strong ability to differentiate between low and normal EF.
  • Imperial College London independent validation: An independent validation of the Low EF AI by the Imperial College London, published in Lancet Digital Health, reported an AUROC of 0.85 for detection of LVEF below 40%, 84.8% sensitivity, and 69.5% specificity when deployed on over 1,050 patients across multiple real-world settings. This validation prompted the UK NHS and Imperial College London to extend Eko’s deployment to over 100 clinics in London and Wales.
  • Demonstrated impact in pregnant women: A clinical study led by Mayo Clinic involving nearly 1,200 pregnant women in Nigeria highlighted the AI’s effectiveness, identifying twice as many cases of pregnancy-related cardiomyopathy than standard care, with an AUROC of 0.98, 100% sensitivity, and 79.4% specificity, underscoring its potential to assist in the detection and appropriate management of cardiomyopathy in pregnant women, reducing associated disease burden and risk of death.

Photo caption: Eko Health’s Low Ejection Fraction (Low EF) AI

Photo credit: Eko Health