Ultromics’ Coronary Artery Disease AI Solution Gets Cleared by FDA

Oxford, UK-based Ultromics has received 510(k) clearance for EchoGo Pro, an artificial intelligence (AI)-based service that can automatically identify coronary artery disease (CAD) from echocardiogram images.

Developed at the University of Oxford, the service will be offered as a module for the company’s EchoGo suite, a tablet-based AI product that supports cardiac imaging diagnosis by providing reports within minutes.

The product gives clinicians “additional insights, derived from AI models trained on large datasets in Oxford,” to support more accurate diagnosis, the company said.