This time it’s the software. We’ve written numerous times about Eko’s Duo digital stethoscope. Last week the FDA granted Breakthrough Device status to the artificial intelligence algorithm designed to detect heart failure. The designation is granted to innovations with the demonstrated potential to advance medical response to life-threatening or irreversibly debilitating diseases. This status accelerates regulatory review so that the device comes to market as soon as possible (assuming the device delivers on its promise).

The Eko algorithm helps identify reduced Left Ventricular Ejection Fraction (LVEF), a common diagnostic measure for heart failure. The test analyzes 15 seconds of sound data collected by the Eko DUO digital stethoscope. Until now, LVEF image analysis has required echocardiography, which is not commonly conducted with physical exams. The FDA Breakthrough Device status designation recognizes the significance of early diagnosis for patients with heart failure. Delayed diagnosis of patient heart failure makes it more difficult to provide effective life-prolonging treatment.

Eko CEO and co-founder Connor Landgraf underscored the importance of the LVEF algorithm. “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.”