Ultromics receives FDA clearance for EchoGo Pro; a first-of-kind solution to help diagnose CAD

EchoGo Pro is an AI service for automated identification of coronary artery disease

• FDA gives 510(K) clearance for EchoGo Pro, expanding the use of Ultromics’ EchoGo service to support clinicians diagnosing coronary artery disease
• Every year in the U.S. over 800,000 people die from heart disease – accounting for 1 in every 3 deaths - around 160,000 are under the age of 65.
• Coronary artery disease (CAD) is the most common form of heart disease and affects over 16.5 million people over the age of 20.
• by 2035, the economic burden of CAD will be in the region of $749 billion in the U.S alone.
  
  

OXFORD, England, Jan.6,2021/ A world-first, AI powered, outcomes-driven, decision support tool – EchoGo Pro, has been cleared by the FDA and is now available to clinicians across the U.S. EchoGo Pro was trialed and validated in the UK and US, improving the diagnostic accuracy of clinicians for Coronary Artery Disease (CAD), the most common form of heart disease and leading cause of death in the U.S.

CAD indications can be subtle. Misdiagnosis happens with one in five patients potentially resulting in poor treatment and outcomes, which is compounded by the subjectivity of interpretation between clinicians. With the use of EchoGo Pro clinicians have additional insights, derived from AI models trained on large datasets in Oxford, which are valuable in the assessment of CAD, improving disease prediction and supporting more accurate diagnosis. This should lead to earlier suitable interventions, reducing cardiac events and improving patient care.

Dr Ross Upton, founder and CEO of Ultromics, comments: “Coronary artery disease is a huge global burden, affecting tens of millions of peoples’ lives worldwide. Heart disease is the biggest killer globally and this number is increasing daily. Our goal is to help doctors detect CAD more accurately, improving patient outcomes and saving lives.”

Ultromics will offer EchoGo Pro as a Stress-Echo module in the EchoGo suite alongside EchoGo Core, its AI solution for automated Systolic function and Strain analysis. The EchoGo suite is a cloud-based service that uses artificial intelligence to fully automate the pathway to diagnosis, providing near-instant reports for clinicians without any need for physical software on site. By automating echocardiogram analysis as part of a cloud service, Ultromics hopes to save clinicians even more time when compared to traditional on-site solutions.

“COVID-19 has placed an even greater pressure on cardiac care and looks likely to have lasting implications in terms of its impact on the heart” explained Dr Upton. “The healthcare industry needs to quickly pivot towards AI powered automation to reduce the time to diagnosis and improve patient care. To help support this shift and save countless lives we are making the EchoGo suite as complete and automated as possible to help clinicians rapidly assess disease and provide early, appropriate intervention. FDA approval for EchoGo Pro is the next step on our innovation journey to transform echocardiography and impact patients' lives”

EchoGo Pro is now clinically available in the EU and U.S., and is being rolled out in the NHS as part of the prestigious NHSx award and assessed at Mayo Clinic. To learn more about Ultromics and how EchoGo could benefit medical practices and patients, visit www.ultromics.com

Notes to editors

Cardiovascular disease is a leading cause of mortality worldwide, representing 31% of all global deaths, with an estimated 17.9 million deaths annually.

About Ultromics

Ultromics is a global health technology firm which provides autonomous echocardiography analysis through innovative AI solutions - empowering clinicians to make fast, accurate decisions when diagnosing cardiovascular disease. We have developed the first fully automated solution for echocardiography and strain analysis. The revolutionary platform, EchoGo, is a cloud-based AI service which delivers analysis to any vendor within minutes and with zero variability through its zero-click, full automation workflow. Our technology was born at the University of Oxford and built-in partnership with the NHS and has since raised over £20 million to help bring diagnostic quality to hospitals, improve patient care, and help make valuable resource and cost savings. Cardiovascular disease is the leading cause of mortality, with an estimated 17 million deaths each year. For more information about Ultromics - http://www.ultromics.com/