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.