Ultromics’ EchoGo® Amyloidosis, clinical AI for echocardiography with the potential to revolutionize early detection of Cardiac Amyloidosis

THE BAJA POST
NEWSROOM
SOURCE: PR NE WSMEDIA

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 a single routinely acquired echocardiographic clip, EchoGo® Amyloidosis needs substantially less clinical information to facilitate detection of the disease compared to current approaches.

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.

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This development, in collaboration with Janssen Biotech, Inc., a Johnson & Johnson Company, and with support from Pfizer, motivated by their continued commitment to expediting the suspicion, diagnosis and clinical outcomes of Light Chain and ATTR Cardiac Amyloidosis, respectively. Janssen supported the development of the device, while Pfizer supported expediting the performance testing and validation ahead of the regulatory submission.

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.»