FDA Clears AI-Based Cardiac Amyloidosis Detection Software

Ultromics' EchoGo Amyloidosis, a clinical AI solution for echocardiography, has received 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 reportedly makes EchoGo Amyloidosis the first commercially available software-only medical device to facilitate detection of Cardiac Amyloidosis using echocardiography. Requiring a single routinely acquired echocardiographic clip, EchoGo Amyloidosis needs substantially less clinical information to facilitate detection of the disease compared to current approaches.

EchoGo Amyloidosis is an AI-powered tool designed to enhance the detection and management of Cardiac Amyloidosis, specifically tailored to address common diagnostic challenges in this underdiagnosed condition. Leveraging standard echocardiogram images, it enables clinicians to identify potential cases with enhanced accuracy and efficiency, requiring only a single apical 4-chamber echo video clip.

Ultromics, a spin-out company from the University of Oxford (UK), has expanded its portfolio of FDA-cleared, AI-based Echo diagnostics to include EchoGo Amyloidosis. This development was in collaboration with Janssen Biotech, Inc., a Johnson & Johnson Company, and with support from Pfizer.

Ross Upton, PhD, CEO and Founder of Ultromics, said, "Echocardiography is a powerful tool for evaluating cardiac structure and function and is central to the detection and monitoring of disease. 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."

The ability to automatically detect and flag potential Cardiac Amyloidosis with limited clinical information has important practical ramifications, particularly for screening, in clinical centers without the time, resource, or expertise to identify Cardiac Amyloidosis from the echocardiogram, which often has an unspecific presentation on the imaging.

Prof Sanjiv J. Shah, MD, Northwestern University, said, "Improving the detection of Cardiac Amyloidosis is vital as early detection provides the greatest therapeutic benefit for patients. Novel AI-based diagnostic tools such as EchoGo Amyloidosis from Ultromics should help facilitate disease identification, particularly in clinics and hospitals restricted by expertise and resource. With more therapies becoming available, the FDA approval of EchoGo Amyloidosis is timely."