Ultromics obtains Breakthrough Device FDA clearance for its Cardiac Amyloidosis screening device through the Total Product Lifecycle Advisory Program | PR Newswire [Video]

EchoGo^® Amyloidosis is an AI-based software-only medical device, which aims to improve early detection of Cardiac Amyloidosis, an underdiagnosed cause of heart failure.

EchoGo^® Amyloidosis sits on Ultromics’ EchoGo^® platform complementing the existing commercialized EchoGo^® Heart Failure device.

, /PRNewswire/ — Ultromics’ EchoGo^® Amyloidosis, clinical AI for echocardiography with the potential to revolutionize early detection of Cardiac Amyloidosis, has received US Food and Drug Administration (FDA) clearance. This milestone marks EchoGo^® Amyloidosis as the first device enrolled in the FDA’s Total Product Lifecycle Advisory Program (TAP) to achieve marketing authorization. The device was among 15 breakthrough cardiovascular devices, to participate in the initial pilot launch phase of the FDA Total Product Lifecycle Advisory Program (TAP) which has since expanded with 55 companies currently enrolled.

This clearance makes EchoGo^®Amyloidosis the first commercially available software-only medical device to facilitate detection of Cardiac Amyloidosis using echocardiography. Requiring …