Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core
OXFORD, England, Nov. 14, 2019 /PRNewswire/ -- Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its image analysis system, EchoGo Core.
The clearance is a major milestone for Ultromics and enables the business to make EchoGo available to clinicians and healthcare providers in the US. EchoGo applies artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans.
Ross Upton, founder and CEO of Ultromics, 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 has been years in development, from the first trial being set-up in 2011 to Ultromics spinning out of the University of Oxford in 2017, and now achieving FDA clearance. The next stage of growth is commercializing the product and making it available to clinicians.
Traditionally, echocardiography has relied on the expert eye of clinicians, with years of experience, measuring the anatomical structures and identifying the disease, a potentially time-consuming and highly variable process. 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.
EchoGo uses AI to calculate left ventricular ejection fraction (EF), the most frequently used measurement of heart function, left ventricular volumes (LV) and, for the first time for an AI application, automated cardiac strain.
Mr. Upton continues, "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".
"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."
Ultromics has partnerships with leading cardiology clinical centres in the United States and 30 NHS centres in the UK. Through this, it is continuously optimizing its scanning algorithms by analyzing 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 dataset, from one of the largest echo studies of its kind.
EchoGo is a vendor-neutral platform, which harmoniously integrates into the medical imaging environment, seamlessly providing clinicians with results as part of their routine diagnostic workflow. This ensures fast, efficient and accurate AI-assisted echocardiogram analysis, to enable the highest quality patient care in healthcare institutions globally.
To learn more about Ultromics and how EchoGo could benefit medical practices and patients, visit www.ultromics.com
Notes for editors
A 510(K) clearance is a premarket submission made to the FDA demonstrating substantial equivalence of the device to a currently marketed device.
Ross Upton is a Forbes 30 Under 30 2019 honoree.
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