AI system for ultrasound-based heart scans receives FDA approval

Ultromics, a U.K.-based healthcare technology company, has gained FDA clearance for its new AI-powered image analysis solution.

The company’s EchoGo Core system uses AI technologies to automate the interpretation of ultrasound-based heart scans. The vendor-neutral solution calculates a patient’s ventricular ejection fraction, left ventricular volumes and automated cardiac strain.

“Strain has shown to be very valuable in cardiovascular diagnostics and has been demonstrated in published studies to be linked with earlier detection of disease and improved patient outcomes,” Ross Upton, founder and CEO of Ultromics, said in a prepared statement. “Ultromics will be the first to use artificial intelligence for automated strain analysis, which is applicable to 60 million scans per year. Crucially, strain is also becoming reimbursable from January 2020 in the U.S.”

The first clinical trial to investigate EchoGo’s effectiveness began back in 2011. The company said it is now ready for this “next stage of growth” to begin.

“This is an incredibly exciting step towards the future of healthcare, EchoGo will help clinicians make more accurate and informed decisions to improve patient care delivery,” Upton said. “It's truly a watershed moment for Ultromics.”