Ultromics granted FDA Breakthrough Device Status

British company Ultromics has been granted FDA Breakthrough Device Status for its artificial intelligence (AI)-enhanced platform for detecting cardiac amyloidosis.

EchoGo Amyloidosis uses AI technology to analyse echocardiograms to detect the presence of cardiac amyloidosis. It does this through a single commonly acquirec ultrasound view of the heart.

By supporting the early diagnosis of the condition it allows treatment to start promptly, ultimately improving patient outcomes.

FDA Breakthrough Device Designation recognises the novel innovations that have demonstrated the potential for providing more effective treatment or diagnosis for life-threatening or debilitating diseases.

The Ultromics EchoGo Amyloidosis platform is the company’s second technology to receive FDA Breakthrough Device Status in the last year. In 2022, its EchoGo Heart Failure was also recognised, going on to receive Marketing Authorisation in 2023.

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

“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.”

EchoGo Amyloidosis is intended as a module with Ultromics’ EchoGo platform. It has been developed with data from a number of leading clinical collaborators and also gained support from Janssen Biotech, Inc.

Najat Khan, Ph.D., chief data science officer and global head, strategy & operations at Janssen Research & Development, LLC, 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.”

The Ultromics technology has been built in collaboration with Mayo Clinic and NHS England. It has over $50 million raised capital to support its continued innovation, from the likes of Blue Venture Fund, Optimum Ventures and Oxford Science Enterprises.

EchoGo Amyloidosis is currently in development with the algorithm as a candidate for FDA medical device submission. Regulatory submissions for the US are currently being prepared and the device could be approved for commercialisation as early as 2024.