UK-based health technology firm Ultromics has received clearance from the US Food and Drug Administration (FDA) for its cardiovascular image analysis system, EchoGo Core.

EchoGo applies artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans.

The 510 (K) clearance, pre-market submission, will enable the business to make EchoGo available to clinicians and healthcare providers in the US.

WHY IT MATTERS

More than 600,000 people in the US die from cardiovascular disease each year and it is the largest cause of death globally. Traditionally, echocardiography has relied on experienced clinicians measuring the anatomical structures and identifying the disease, which can be a time-consuming and highly variable process. 

Ultromics says that by automating the process and applying its AI analysis to look in greater detail at the scans, EchoGo enables clinicians to interpret echocardiograms efficiently and accurately and assists in their decision-making.

THE LARGER CONTEXT

Oxford University spin-out, Ultromics was launched in 2017 and in May 2018 announced that it had raised £10m in a Series A round led by Oxford Sciences Innovation.

In 2018, Ultromics set up trials of its echocardiography software, across six cardiology units, which was later extended to 30 NHS hospitals in the UK. It has also partnered with leading cardiology centres in the US. The next stage of growth is commercialising the product and making it available to clinicians.

ON THE RECORD

"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”, said Ross Upton, founder and CEO of Ultromics. "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 AI for automated strain analysis which is applicable to 60 million scans per year. Crucially, strain is also becoming reimbursable from January 2020 in the US. 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.

"We have more developments planned in 2020, including EchoGo Pro. It 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.”