Ultromics’ EchoGo Heart Failure IA Diagnosis Device Cleared

The FDA has granted clearance to Ultromics’ EchoGo Heart Failure device which uses artificial intelligence to diagnose heart failure with preserved ejection fraction (HFpEF) from a single echocardiogram image.

HFpEF is the most common form of heart failure and accounts for 50 percent of cases, increasing at about 1 percent annually because of an aging population with comorbidities of high blood pressure, diabetes and obesity.

The device has shown 90 percent accuracy in detecting HFpEF, a 25 percent increase from current clinical practice, the company said, adding that traditional diagnostics can miss up to 75 percent of cases.

UK-based Ultromics, a spinout from the University of Oxford, worked in collaboration with the Mayo Clinic to develop the device. The FDA previously granted EchoGo Heart Failure Breakthrough Device status.