U.K. software developer Ultromics has entered an agreement with Pfizer to expedite marketing clearance in the U.S. for its AI algorithm for detecting cardiac amyloidosis.
Under the partnership with Pfizer, Ultromics will research and pursue U.S. Food and Drug Administration (FDA) clearance for its EchoGo Amyloidosis algorithm. The software has already received Breakthrough Device designation from the FDA for the detection of cardiac amyloidosis. The algorithm uses deep learning to analyze routine ultrasound scans of the heart (echocardiograms) to detect disease that often goes undetected during standard assessments, Ultromics said.
