EchoGo Amyloidosis, an AI-enhanced platform from Ultromics designed for detecting cardiac amyloidosis, has been granted Breakthrough Device Designation by the U.S. Food & Drug Administration (FDA).
According to a release by PR Newswire, EchoGo Amyloidosis was specifically created to use artificial intelligence to analyze echocardiograms and detect cardiac amyloidosis through a single commonly acquired heart ultrasound. If amyloidosis is left undetected, it can result in delayed treatment. Many patients suffer a 5-year mortality rate of 44-65% after diagnosis if the illness is not caught early enough.
"Receiving a breakthrough designation for EchoGo Amyloidosis, emphasises the importance of this innovation," Dr. Ross Upton, CEO and Founder of Ultromics, said in the release. "This is our second breakthrough designation and brings us one step closer to achieving our goal of providing earlier and more accurate diagnosis for this debilitating, underdiagnosed disease. We are excited to continue working with our partners to bring this technology to market and help improve outcomes for patients."
Cardiac amyloidosis is a complex condition caused by abnormal proteins, called amyloids, building up in heart tissue. It can be difficult to diagnose, typically necessitating specialized expertise and tests. The two primary types of cardiac amyloidosis are transthyretin amyloidosis, triggered by misfolded transthyretin protein, and a less frequent variant known as light chain amyloidosis, which results from the accumulation of immunoglobulin light chains.
The release stated that FDA Breakthrough Device Designation recognizes new innovations that could provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. Dr. Najat Khan, Chief Data Science Officer and Global Head of Strategy and Operations at Janssen Research & Development LLC, said the new technology could drastically reduce adverse outcomes from the disease.
"While treatments exist to help slow or halt the progression of cardiac Amyloidosis, underdiagnosis in the early stages of disease is a huge challenge," he said. "When applied to routine tests like echocardiograms, artificial intelligence is demonstrating exciting potential to help facilitate earlier disease detection – with the goal of connecting patients with treatment sooner and, ultimately, driving better health outcomes."
According to the release, EchoGo Amyloidosis will work with their EchoGo platform. EchoGo Amyloidosis has been developed with data from multiple clinical collaborators and support from Janssen Biotech, Inc. — part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The company is working on regulatory submissions for the United States and plans to receive commercialization approval by early 2024.
