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Eko Health’s Low Ejection Fraction (Low EF) AI, developed in collaboration with Mayo Clinic, gives healthcare professionals the ability to more accurately assess the likelihood of heart failure in at-risk patients during standard physical exams. Provides powerful tools.
San Francisco, April 2, 2024 /PRNewswire/ — Eko Health, a pioneer in applying artificial intelligence (AI) for the early detection of heart and lung diseases, announced FDA clearance of its low EF detection AI. For the first time, a U.S. health care provider can now use her Eko stethoscope to detect low EF, a key heart failure indicator, in his 15 seconds during a routine physical exam. This breakthrough in early detection is both an important medical innovation and a new era in cardiovascular disease discovery.
More than 6 million people in the United States live with heart failure, and half of them experience heart failure with reduced ejection fraction (HFrEF), a condition in which the heart is unable to pump blood effectively.1 Traditional heart failure detection tools, such as echocardiography, are often unavailable in primary care settings because they are expensive, require specialized training, and take significant time. As a result, many cases of heart failure go undiagnosed until symptoms require referral to a specialist or emergency hospital, leading to poor patient outcomes and increased healthcare costs.2 Eko’s Low EF AI challenges this status quo by incorporating rapid and accessible low ejection fraction detection into stethoscope examinations at the forefront of healthcare.
“The ability to identify hidden and potentially life-threatening cardiac conditions using a stethoscope, a tool that primary care and subspecialist clinicians are familiar with, can help prevent hospitalizations and adverse events.” the doctor said. paul friedman, director of cardiology at the Mayo Clinic in Rochester. “Importantly, because the stethoscope is small and portable, this technology can be used in urban and remote areas and is expected to help address care in underserved areas.”
Low EF AI will be added to Eko’s SENSORA Cardiac Early Detection Platform. This is the latest advancement in a platform that already has FDA-cleared algorithms to identify AFib and structural heart murmurs, which are often indicators of valvular heart disease. When primary care testing using SENSORA detects low EF, referral to cardiology for thorough diagnostic testing and treatment evaluation can expedite access to life-sustaining treatment.
“The stethoscope is one of the most recognizable symbols in healthcare, touching an estimated one billion lives around the world each year,” said Connor Landgraf, co-founder and CEO of Eko Health. “With Eko’s Low EF AI, we are transforming a medical icon into an AI-powered heart failure early detection tool, helping millions of patients treat themselves in a fraction of the time and cost of echocardiography. We are proud to collaborate with Mayo Clinic on this groundbreaking initiative.”
Clinical development and validation highlights:
- Robust AI training and validation: Eko’s Low EF AI is trained on a proprietary dataset of over 100,000 ECG and echocardiogram pairs from unique patients and clinically proven in a prospective, multi-center clinical study of 3,456 patients. was validated and achieved an AUROC of 0.835 for detection of LVEF <40%. , with a sensitivity of 74.7% and a specificity of 77.5%, demonstrating strong ability to distinguish between low and normal EF.3
- Imperial College London Independent Verification: Independent validation of the Low EF AI by Imperial College London, published in Lancet Digital Health, showed an AUROC of 0.85 for detection of LVEF below 40% when deployed in more than 1,050 patients in real-world settings. reported a sensitivity of 84.8% and specificity of 69.5%. -World settings. This validation led the UK NHS and Imperial College London to expand the implementation of his Eko to more than 100 of his clinics across the country. London and wales.Four
- Proven effects in pregnant women: A clinical study led by the Mayo Clinic that involved approximately 1,200 pregnant women. Nigeria highlighted the effectiveness of AI, identifying twice as many pregnancy-related cardiomyopathy cases as standard therapy, with an AUROC of 0.98, a sensitivity of 100.0%, and a specificity of 79.4%. Highlighted the huge potential of AI to support management. Pregnant women reduce the associated disease burden and mortality risk.Five
About Eco Health
Eko Health is a leading digital company that is advancing the way healthcare professionals detect and monitor heart and lung diseases with a portfolio of digital stethoscopes, patient and provider software, and AI-powered analytics. A health company. Its FDA-cleared platform is used by more than 500,000 healthcare professionals worldwide, enabling earlier and more accurate detection, more reliable diagnosis, and effective treatment management. Ultimately, you can provide the best possible care to your patients. Eko Health’s headquarters are Emeryville, California,over $125 million Funding includes Artis Ventures, DigiTx Partners, Highland Capital Partners, Mayo Clinic, Morningside Technology Ventures Limited, NTTVC, and Questa Capital.
For more information, please visit www.ekohealth.com.
Mayo Clinic and Dr. Friedman have a financial interest in the technology mentioned in this news release. Mayo Clinic uses proceeds received to support its nonprofit mission in patient care, education, and research.
References:
- Centers for Disease Control and Prevention. (2023, January 5th). heart failure. https://www.cdc.gov/heartdisease/heart_failure.htm
- Bachtiger P, Kelshiker MA, Petrie CF, et al. (2023). Survival and health economic outcomes in heart failure diagnosed at admission versus heart failure in the community: A propensity-matched analysis. BMJ Health & Care Informatics, 30:e100718. doi: 10.1136/bmjhci-2022-100718
- FDA 510(k) Overview, K233409
- Bachtiger, P., et al. (2022). Point-of-care screening for heart failure due to reduced ejection fraction using artificial intelligence during ECG-enabled stethoscope examination london, united kingdom: A prospective, observational, multicenter study. Lancet Digital Health, 4(2).
- Adinsewo DA. (2023, November 13th). Screening for peripartum cardiomyopathy using an artificial intelligence-enhanced digital stethoscope: a randomized clinical trial [Conference Presentation and Abstract]. AHA 2023, Philadelphia, Pennsylvania, America.
Media contact:
Sam Moore
sam.moore@ekohealth.com
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