FDA grants AI algorithm for heart failure Breakthrough Device designation

Eko, a San Francisco-based healthcare technology company, announced that its ECG-based algorithm for heart failure has been granted a Breakthrough Device designation by the FDA.

The algorithm evaluates 15 seconds of ECG data taken from Eko’s DUO digital stethoscope, searching for any possible signs of reduced left ventricular ejection fraction. Such findings are seen as a sign of heart failure.

“The Breakthrough Device designation recognizes the vast unmet clinical needs in identifying heart failure early in patients, whether it be due to cost, inaccessibility, or misdiagnosis,” Connor Landgraf, co-founder and CEO of Eko, said in a prepared statement. “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.”

The algorithm has already been investigated by a team of researchers from Mayo Clinic in Rochester, Minnesota, with the results being published in Nature Medicine in January 2019.

“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,” Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic, said in the same prepared statement. “This technology gives physicians a tool to detect heart disease earlier, and before it develops into a more serious illness. In effect, by imbedding the technology in a commonly used clinical tool—the stethoscope—all caregivers carry some of the diagnostic prowess of an expert cardiologist with them.”