UK-based health technology firm Ultromics has received 510(K) approval from the US Food and Drug Administration for its AI-powered image analysis system, EchoGo Core.
Leveraging artificial intelligence, EchoGo automates analysis and quantification of ultrasound-based heart scans, which helps clinicians to detect cardiovascular disease at an early stage and provides patient care.
Ultromics founder and CEO Ross Upton said: “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. It’s truly a watershed moment for Ultromics”.
EchoGo’s first trial was set up in 2011.
Electrocardiography clinicians usually apply their expertise to measure the anatomical structures and identify the disease, which consumes time.
This vendor-neutral platform integrates the medical imaging system in a synchronised manner, which enables clinicians to get results as part of the regular diagnostic workflow.
The image analysis system uses artificial intelligence to calculate left ventricular ejection fraction (EF), left ventricular volumes (LV) and automated cardiac strain analysis.
Upton said: “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.
“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. EchoGo allows clinicians across a wide range of experience to rapidly obtain accurate and repeatable calculations of strain parameters, assisting them in interpretation of echocardiograms”.
Meanwhile, the company has planned more developments next year, including EchoGo Pro.
Upton added: “We are also planning to expand into other geographic regions including Europe and Asia. Our goal is to improve patient outcomes through earlier detection of cardiac disease.”
Ultromics, which spun out of the University of Oxford in 2017, has partnerships with many cardiology clinical centres in the US and 30 NHS centres in the UK.