EchoGo Pro Receives FDA Clearance Is Now Available to Physicians in the U.S.: 1st of Kind Solution in Echocardiography

January 6, 2020

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 the leading cause of death in the U.S.

Benefits: Accurate and fast analysis to enable physicians at any skill level to feel confident in making diagnostic recommendations to patients. Full automation reduces variability.

Identifies indications of ischemia (CAD) with increased sensitivity, helping to detect early signs and enable preventative steps before a heart attack strikes, ultimately saving lives.

Allows improved identification of at-risk individuals to be treated quickly – and those not at risk to be spared from unnecessary tests, surgery and treatment.

The system is zero click. Echocardiograms are automatically sent to Ultromics for analysis and a report is returned within minutes.

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

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.

EchoGo Pro was trialed in the UK and US and achieved a diagnostic performance of over 90% (AUROC), significantly reducing the number of misdiagnoses compared to reports of routine clinical practice. The technology has been validated and developed through its partnership in the EVAREST trial with the NHS, one of the largest ultrasound programmes in the world. It’s trained on past clinical examples, to spot thousands of features, compared to a handful of indicators in traditional visual inspection. The EVAREST validation trial continues to run in over 30 NHS hospitals and has recruited over 6000 patients to date.

Performance Of The Coronary Artery Disease Classifier:

EchoGo Pro uses novel features derived from Stress Echo images and machine learning algorithms. The system was tested on an independent validation dataset demonstrating an area under the ROC curve of 0.927.

In a reader study to evaluate the benefit of EchoGo Pro in clinical settings, clinicians performed significantly better by diagnostic accuracy, with the aid of EchoGo Pro.

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