SENSORA™ Low Ejection Fraction (Low EF) helps detect signs of heart failure by flagging reduced ejection fraction in a physical exam.
Echocardiography is often inaccessible in primary care settings due to required training, limited time, and added cost. SENSORA™ Low EF pairs the Eko stethoscope with powerful low EF detection AI, enabling rapid identification of reduced ejection fraction in a primary care setting. In the case of a positive result, providers can consider a referral for an echocardiogram or cardiology consult.
Time is a precious resource in primary care. SENSORA™ Low EF will enable clinicians to analyze heart sound and ECG data for ejection fraction below 40% in 15 seconds, ensuring minimal interruption to clinical workflow. By incorporating AI into the stethoscope exam, SENSORA™ Low EF helps keep visits on track without a major learning curve.
4Eko’s Low EF AI was trained on a proprietary dataset of over 100,000 ECGs and echocardiogram pairs from unique patients, and was clinically validated in a multi-site, prospective clinical study of 3,456 patients, achieving an AUROC of 0.835 for detection of LVEF ≤40%, 75% sensitivity and 78% specificity for adults with a risk factor, demonstrating a strong ability to differentiate between low and normal EF.
5An independent validation of Eko’s Low EF AI by the Imperial College London, published in Lancet Digital Health, reported an AUROC of 0.85 for detection of LVEF ≤40%, 85% sensitivity, and 70% specificity when deployed on over 1,050 patients across multiple real-world settings. This research prompted the UK NHS and Imperial College London to extend Eko’s deployment to over 100 clinics in London and Wales.
6References
(1) Bachtiger P, Kelshiker MA, Petri CF, et al. (2023). Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health & Care Informatics, 30:e100718. doi: 10.1136/bmjhci-2022-100718
(2) Centers for Disease Control and Prevention. (2023, January 5). Heart failure. https://www.cdc.gov/heartdise.
(3) Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America, Journal of Cardiac Failure, 23 Sept. 2023.
(4) Butler J, Fonarow GC, Gheorghiade M. Need for Increased Awareness and Evidence-Based Therapies for Patients Hospitalized for Heart Failure.JAMA.2013;310(19):2035–2036. doi:10.1001/jama.2013.282815
(5) FDA 510(k) Summary, K233409
(6) Bachtiger, P., et al. (2022). Point-of-care screening for heart failure with reduced ejection fraction using artificial intelligence during ECG-enabled Stethoscope Examination in London, UK: A prospective, observational, multicentre study. The Lancet Digital Health, 4(2).
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