Eko Devices, Inc. released earlier this month results from a study published in The Lancet. It showed that the AI-powered Eko Duo ECG+ Digital Stethoscope could screen for heart disease.
In 2018 we wrote about Eko’s collaboration with the Mayo Clinic to develop an algorithm to help physicians screen for low ejection fraction. After the Eko Duo’s FDA Breakthrough Device designation in 2019 and FDA Clearance in 2020, in 2021 Eko announced the next generation Duo platform with FDA-cleared deep learning algorithms for physician use in non-clinical settings. Eko and Mayo Clinic have developed the ELEFT algorithm for screening patients with weak heart pumps.
The latest study was conducted by researchers at Imperial College of London and published its results. The study included 1,050 National Health Service patients. The study involved 1,050 National Health Service patients. 945 patients had left-ventricular ejection fractions (LVEF) at least 40% and 105 had LVEFs of less than 40%. Ejection fraction is a quantitative measure of the heart’s ability to pump blood. Eko states that a lower LVEF (or 40%) is the threshold to diagnose reduced ejection fraction. This is a common symptom in patients with heart failure. Eko ECG-enabled digital stethoscope, the Duo ECG-enabled Duo, was used to measure each patient’s ejection fraction in four positions using a single-lead ECG. AI-ECG is an algorithm that has been validated to detect a reduced LVEF. The data was analyzed by the researchers using both devices. The researchers also tested the subjects using transthoracic echocardiograms, which are the most reliable method of measuring ejection fraction.
The Eko Duo and single-lead ECG were able detect LVEFs of 40 to 40%, according to the study. The single-lead ECG results varied depending on the reading positions. However, when the researchers combined the best single lead ECG position with the handheld position, they achieved 91.9% sensitivities (true positive reading) as well as 80.2% specificity. The report noted the platform’s potential for inexpensive, non-invasive, point-of-care screening to aid earlier diagnosis.
FDA clearance is not available for the Eko Duo ECG+ Digital Stethoscope and ELEFT in order to detect heart disease. The algorithm will be submitted to Breakthrough Designation review by the collaboration for possible clearance in 2022. Eko Duo ECG + Digital Stethoscope can be purchased on the EkoHealth website for $399. Only doctors and patients who have a prescription for approved functions are allowed to purchase the Eko Duo ECG + Digital Stethoscope.
We asked Eko representatives whether the company has protocols for telemedicine applications that allow remote patient monitoring. We were interested in knowing if patients can self-test with the Duo, and then transmit the results to their care teams via the mobile application. Eko responded, “We have health system partners who do use the DUO for clinician-directed at-home care, using telehealth, but these protocols tend to be customized based on the telehealth solutions the specific health partner has in place.” Eko also included a link to this video about at-home telemedicine. With OTC approval in the U.S. we may be able look forward towards patient-directed protocols.
