Ultromics Limited has entered into an agreement with Pfizer to support the validation and FDA clearance of its AI-based technology for the detection of cardiac amyloidosis. Under the partnership with Pfizer, Ultromics will research and pursue FDA clearance for its EchoGo® Amyloidosis algorithm that already has Breakthrough Device Designation as a medical device for the detection of cardiac amyloidosis. The algorithm uses deep learning to analyse routine ultrasound scans of the heart (echocardiograms) to detect disease that often goes undetected during standard assessments.

Cardiac amyloidosis is a heterogeneous disease that results from the accumulation of abnormal proteins within the heart, impairing its ability to pump blood. Over time, the build-up of these proteins causes the heart muscle to stiffen, eventually leading to heart failure, which can have dire outcomes if not found early. Ultromics' expertise has been demonstrated through its algorithms for improving the detection of Heart Failure, which previously received FDA Breakthrough Device Designation before being cleared by the FDA in November 2022.

FDA Breakthrough Device Designation recognizes novel innovations that demonstrate the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This builds on the history of Echo diagnostic algorithms developed by Ultromics including the first ever AI diagnostic, EchoGo® Pro for the detection of coronary artery disease, which was FDA cleared in 2021 and is undergoing a prospective clinical trial in the UK.