Oxford, UK-based Ultromics has entered into an agreement with Pfizer to support the development of its AI-based technology for the detection of cardiac amyloidosis.
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.
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.
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.
In December 2023, Ultromics proudly revealed it had been chosen to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot, an exclusive cohort comprising of only 15 breakthrough cardiovascular devices. The strategic initiative is geared towards accelerating development and enhancing the accessibility of high-quality, safe, effective, and innovative medical devices.
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