UK medtech gets FDA clearance for AI device that measures cardiac strain

14 Nov 2019230 Views

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Ultromics, a spin-out of the University of Oxford, has received FDA clearance for its AI medical device EchoGo.

Today (14 November), British medtech company Ultromics announced that it has received 510(k) FDA clearance for its AI-powered medical device.

A 510(K) is a pre-market submission made to US Food and Drug Administration (FDA) to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device.

Spun out from the University of Oxford in 2017 by Ross Upton and Prof Paul Leeson, Ultromics has developed a device called EchoGo, which applies AI to automate the analysis and quantification of ultrasound-based heart scans.

Traditionally, echocardiography has relied on the expert eye of clinicians with years of experience, measuring the anatomical structures and identifying the disease, but EchoGo uses AI to measure heart function and cardiac strain.

The company said: “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.”

‘Improved patient outcomes’

Upton, who serves as CEO of the company, 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 60m scans per year. Crucially, strain is also becoming reimbursable from January 2020 in the US. EchoGo allows clinicians from a wide range of experience to rapidly obtain accurate and repeatable calculations of strain parameters, assisting them in interpretation of echocardiograms.”

While Ultromics officially launched as a spin-out of the University of Oxford in 2017, research into EchoGo began several years earlier. The first trial of the product was set up in 2011.

Plans for the future

EchoGo will now be available for clinicians in the UK and the US to identify the early stages of cardiovascular disease.

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

“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. Our goal is to improve patient outcomes through earlier detection of cardiac disease.”

The company has existing partnerships with cardiology clinical centres in the US and 30 NHS centres in the UK. Through these partnerships, Ultromics is continuously optimising its scanning algorithms by analysing the archive of scans held by these centres.

The pipeline of AI algorithms underpinning EchoGo was built using thousands of images from a carefully curated data set.

Kelly Earley is a journalist with Siliconrepublic.com

editorial@siliconrepublic.com