Ultromics has received breakthrough device designation from the US Food and Drug Administration (FDA) for its EchoGo Amyloidosis platform to detect cardiac amyloidosis with the help of artificial intelligence (AI).
The UK-based digital health technology company said that the platform assesses echocardiograms and detects cardiac amyloidosis, caused by abnormal protein deposits in the heart tissue.
According to Ultromics, the EchoGo Amyloidosis platform uses only a single commonly acquired ultrasound anatomy of the heart.
The digital health technology has designed the technology to fill the gap in patient care by providing an early diagnosis of amyloidosis, thus accelerating treatment and improving patient outcomes.
Ultromics CEO and founder Ross Upton 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.”
EchoGo Amyloidosis, which was designed as a module within Ultromics’ EchoGo Platform, was created using data from different clinical collaborators. It also received assistance from Janssen Biotech, a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson.
EchoGo is said to provide clinicians with precise, efficient, and accurate assessments of heart failure, using the heart disease outcomes dataset in echocardiography.
Developed in collaboration with Mayo Clinic and National Health Service (NHS) England, the platform is said to interpret echocardiograms accurately and predict cardiac outcomes.
Currently, Ultromics is planning regulatory submissions for the US, and the amyloidosis detection device could be cleared for commercialisation in 2024.
The algorithm for EchoGo Amyloidosis is currently in development as a candidate for FDA medical device submission.
Ultromics’ HFpEF device, EchoGo Heart Failure device secured breakthrough device designation in 2022 followed by marketing authorisation in 2023.
