Ultromics has secured clearance from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-based echocardiography software for the detection of heart failure with preserved ejection fraction (HFpEF).
EchoGo Heart Failure uses AI to identify HFpEF from a single echocardiogram image, according to the firm.
The clearance come just weeks after Ultromics joined the Foundation for the National Institutes of Health Accelerating Medicines Partnership Heart Failure program, which is a collaboration between the National Institutes of Health, the National Heart Lung and Blood Institute, the FDA, the American Heart Association, the American Society of Echocardiography, and industry, the company said.
