www.fdanews.com/articles/193456-fda-clears-ultromics-ai-powered-echocardiography-tech-to-calculate-automated-cardiac-strain
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FDA Clears Ultromics’ AI-Powered Echocardiography Tech to Calculate Automated Cardiac Strain
November 14, 2019
Ultromics has received 510(k) clearance from the FDA for its AI-powered technology, EchoGo, which assists in the measurement of heart functions, including automated cardiac strain.
The technology automatically analyzes ultrasound-based heart scans to calculate cardiac strain. It is the first AI application cleared for that use. EchoGo also measures left ventricular ejection fraction and left ventricular volumes.
"Strain has shown to be very valuable in cardiovascular diagnostics” and has been linked with earlier detection of disease and improved patient outcomes, said Ultromics CEO Ross Upton.