Digital health firm Eko Devices has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its ECG-based low ejection fraction screening algorithm.

Developed in collaboration with Mayo Clinic, the algorithm helps to identify Left Ventricular Ejection Fraction (LVEF), a measure commonly used to diagnose patients with heart failure.

Eko’s ECG-based algorithm deploys a deep neural network to analyse 15 seconds of ECG data obtained from a digital stethoscope (Eko DUO) during a physical examination.

Eko CEO and co-founder Connor Landgraf said: “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.

“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.”

In the US, nearly 5.7 million people suffer from heart failure conditions.

Clinical studies conducted at Mayo Clinic revealed that the DUO, together with the AI algorithm, successfully detected ejection fraction < 35% with an area under the curve (AUC) of 0.90.

Mayo Clinic Department of Cardiovascular Medicine chair Paul Friedman said: “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.”

In November, Eko Devices released the second generation of its CORE digital stethoscope technology to enable medical professionals to screen for heart ailments.