U.K.-based health tech firm Ultromics has secured 510(K) FDA clearance for its EchoGo Core image analysis system, the company announced Nov. 14.
EchoGo leverages artificial intelligence to calculate left ventricular ejection fraction, LV volumes and automated cardiac strain on ultrasound-based heart scans. The idea, founder and CEO Ross Upton said, is to automate the analysis and quantification of echos so cardiologists can make more informed decisions about care delivery.
“This is an incredibly exciting step toward the future of healthcare,” Upton, a Forbes “30 Under 30” honoree this year, said in a statement, calling the 510(K) clearance “truly a watershed moment” for his company.
Notably, the FDA’s choice to clear Ultromics’ technology means it will be available to a wider population of patients and providers. Based in the U.K., the company has only been independent of the University of Oxford for two years.
Upton said the EchoGo system will make Ultromics the first tech company to use AI for automated strain analysis, which is applicable to some 60 million scans per year and will be reimbursable in the U.S. starting in January. He said EchoGo could be a useful tool for physicians of all experience levels looking to learn more about strain calculations and improve their interpretation of echocardiograms.
The company is already looking ahead to next year, when Upton and his team plan to launch the EchoGo Pro—something they’re promising will be “the first AI system able to predict cardiac disease from echocardiography.”
“We are also planning to expand into other geographic regions, including Europe and Asia,” Upton said. “Our goal is to improve patient outcomes through earlier detection of cardiac disease.”