Eko has announced that the FDA has granted the company breakthrough status for its ECG-based algorithm that is designed to provides easily accessible screening test for heart failure. A press release reports that the algorithm analyses 15 seconds of ECG data collected from the Eko DUO digital stethoscope during a physical exam. It adds that the device helps identify reduced left ventricular ejection fraction (LVEF).
According to the press release, Eko’s low ejection fraction algorithm employs a deep neural network developed in collaboration with Mayo Clinic. The algorithm was first announced in a landmark publication in Nature Medicine in January 2019. In further clinical studies at Mayo Clinic, the DUO combined with the AI algorithm was able to detect ejection fraction <35% with an area under the curve (AUC) of 0.90. Mayo Clinic and Paul Friedman (Department of Cardiovascular Medicine, Mayo Clinic, Rochester, USA).
Connor Landgraf, CEO and co-founder of Eko, comments: “The Breakthrough Device designation recognises the vast unmet clinical needs in identifying heart failure early in patients, whether it be due to cost, inaccessibility, or misdiagnosis. We look forward to working with the FDA to bring this algorithm to patients and to give clinicians a new tool to screen for low ejection fraction.”
Friedman says: “A low ejection fraction means that the heart pump is weak, which can lead to shortness of breath, swelling, exercise intolerance, or sudden death, so it is important to identify, as many treatments exist. This technology gives physicians a tool to detect heart disease earlier, and before it develops into a more serious illness. In effect, by embedding the technology in a commonly used clinical tool—the stethoscope—all caregivers carry some of the diagnostic prowess of an expert cardiologist with them.”