FDA Clears AI Image Analysis System to Help Clinicians Interpret Echocardiograms

Samara Rosenfeld
NOVEMBER 14, 2019
fda

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Ultromics’ artificial intelligence (AI) image analysis system which aims to help clinicians interpret echocardiograms and improve patient care delivery.

The health technology company’s tool, EchoGo Core, uses AI built using thousands of images from a curated data set to automate the analysis and quantification of ultrasound-based heart scans. The technology helps calculate left ventricular ejection fraction, left ventricular volumes and automated cardiac strain.

Echocardiography typically relies on an expert’s eyes measuring the anatomical structures and identifying the disease. This method is time intensive and highly variable, Ultromics 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,” the company claimed.

EchoGo aids clinicians with varying experience in obtaining accurate and repeatable calculations of strain parameters to interpret echocardiograms, said Ross Upton, Ph.D., CEO and founder at Ultromics.

The FDA clearance will help make the UK-based company’s technology available to clinicians and providers in the U.S.

“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 and delivery.”

And Ultromics is not stopping at this FDA approval.

The company plans to roll out EchoGo Pro, an AI system to help predict cardiac disease from echocardiography, in 2020. Ultromics also wants to expand to other geographic areas including Europe and Asia.

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

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