Ultromics has received breakthrough device status from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-enhanced platform to detect cardiac amyloidosis.
Referred to as EchoGo Amyloidosis, the platform leverages AI to analyse echocardiograms and detect cardiac amyloidosis from a single, commonly obtained ultrasound view of the heart.
Cardiac amyloidosis is a heterogeneous disease that arises from the accumulation of abnormal proteins in the heart tissue.
Ultromics CEO and founder Dr Ross Upton said: “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.”
Developed in conjunction with various clinical collaborators and supported by Janssen Biotech, EchoGo Amyloidosis forms an integral part of the company’s EchoGo Platform.
Ultromics is currently working on regulatory submissions for the US, with the goal of obtaining approval for the device to push for commercialisation by early next year.
Janssen research and development strategy and operations global head and chief data science officer Dr Najat Khan said: “When applied to routine tests like echocardiograms, AI 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.”
Last year, Ultromics received a breakthrough device designation for its HFpEF device, EchoGo Heart Failure, while marketing authorisation was received this year.