Ultromics’ AI platform for detecting cardiac amyloidosis gains FDA breakthrough status


AIUltromics has been granted US Food and Drug Administration (FDA) breakthrough device status for its AI-enhanced platform for detecting cardiac amyloidosis.

The platform, EchoGo Amyloidosis, uses artificial intelligence to analyse echocardiograms and detect the presence of cardiac amyloidosis. The novel technology is designed to address the unmet need for earlier diagnosis of amyloidosis patients, which otherwise may go unnoticed until the disease has advanced, delaying treatment, and adversely impacting patient outcomes.

“Receiving a breakthrough designation for EchoGo Amyloidosis, emphasises the importance of this innovation,” said Dr Ross Upton, CEO and Founder of Ultromics. “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.”

FDA breakthrough device designation recognises novel innovations that demonstrate the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.

The product, intended as a module within Ultromics’ EchoGo Platform, has been developed with data from several leading clinical collaborators and with support from Janssen Biotech. The company is preparing regulatory submissions for the USA, and the device could be approved for commercialisation as soon as early 2024.

Ultromics’ Amyloidosis platform is the company’s second technology to receive FDA breakthrough device designation within the last year. Its HFpEF device, EchoGo Heart Failure received breakthrough device designation in 2022 and marketing authorisation in 2023. EchoGo Amyloidosis is currently in development with the algorithm as a candidate for FDA medical device submission.


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