Oxford’s Ultromics AI tool receives FDA clearance to help clinicians diagnose disease


EchoGo Pro, developed by Oxford-based Ultromics, a world-first, AI powered decision support tool, has been cleared by the US Food & Drug Admininstration (FDA) and is now available to clinicians across the U.S.

EchoGo Pro was trialed and validated in the UK and US, improving the diagnostic accuracy of clinicians for Coronary Artery Disease (CAD), the most common form of heart disease and leading cause of death in the U.S.

CAD indications can be subtle. Misdiagnosis happens with one in five patients potentially resulting in poor treatment and outcomes, which is compounded by the subjectivity of interpretation between clinicians.

With the use of EchoGo Pro clinicians have additional insights, derived from AI models trained on large datasets in Oxford and supporting more accurate diagnosis. This should lead to earlier suitable interventions, reducing cardiac events and improving patient care.

Dr Ross Upton, founder and CEO of Ultromics, said: “Coronary artery disease is a huge global burden, affecting tens of millions of peoples’ lives worldwide. Heart disease is the biggest killer globally and this number is increasing daily. Our goal is to help doctors detect CAD more accurately, improving patient outcomes and saving lives.”

Ultromics will offer EchoGo Pro as a Stress-Echo module in the EchoGo suite alongside EchoGo Core, its AI solution for automated Systolic function and Strain analysis. The EchoGo suite is a cloud-based service that uses artificial intelligence to fully automate the pathway to diagnosis, providing near-instant reports for clinicians without any need for physical software on site.

“COVID-19 has placed an even greater pressure on cardiac care and looks likely to have lasting implications in terms of its impact on the heart” explained Dr Upton. “The healthcare industry needs to quickly pivot towards AI powered automation to reduce the time to diagnosis and improve patient care. To help support this shift and save countless lives we are making the EchoGo suite as complete and automated as possible to help clinicians rapidly assess disease and provide early, appropriate intervention. FDA approval for EchoGo Pro is the next step on our innovation journey to transform echocardiography and impact patients’ lives”

EchoGo Pro is also being rolled out in the NHS as part of the prestigious NHSx award and assessed at Mayo Clinic.

Cardiovascular disease is a leading cause of mortality worldwide, representing 31 per cent of all global deaths, with an estimated 17.9 million deaths annually.