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.
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.
This development, in collaboration with Janssen Biotech, Inc., a Johnson & Johnson company, and supported by Pfizer, aims to expedite the suspicion, diagnosis, and clinical outcomes of Light Chain and ATTR Cardiac Amyloidosis. Janssen’s role was to support the device’s development, while Pfizer focused on accelerating performance testing and validation in preparation for regulatory submission. Both companies are committed to advancing the treatment and diagnosis of these serious conditions.
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.”
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