FDA OKs Ultromics’ Cardiac Amyloidosis AI Screening Device

Ultromics has received U.S. Food and Drug Administration (FDA) clearance for EchoGo amyloidosis, clinical artificial intelligence (AI) for early detection of cardiac amyloidosis.

The clearance makes EchoGo amyloidosis the first commercially available software-only medical device to aid detection of cardiac amyloidosis using echocardiography. It requires a single, routinely acquired echocardiographic clip—substantially less info to spot the disease compared to current approaches.

The milestone also marks the technology as the first device enrolled in the FDA’s Toal Product Lifecycle Advisory Program (TAP) to gain marketing authorization. It was among 15 breakthrough cardiovascular devices to participate in the initial pilot launch phase of the FDA TAP, which has since grown to 55 companies currently enrolled.

Ultromics is a spinout company from the UK’s University of Oxford. Janssen Biotech, a Johnson & Johnson company, supported the device’s development. Pfizer supported expediting performance testing and validation ahead of regulatory submission.

The ability to automatically spot and flag possible cardiac amyloidosis with limited clinical info has ramifications in screening in clinical centers without the time, resources, or expertise to identify it from the echocardiogram.

“Echocardiography is a powerful tool for evaluating cardiac structure and function and is central to the detection and monitoring of disease,” said Ultromics founder and CEO Ross Upton, Ph.D. “However, there are some diseases that are very challenging for even the most expert clinician to detect on an echocardiogram. Requiring only a single apical 4 chamber image, EchoGo Amyloidosis identifies Cardiac Amyloidosis, and will help drive earlier access to appropriate treatment and care for patients with this underdiagnosed disease.”