Cardiological AI gets 510(k) nod

The FDA has cleared UK-based Ultromics to sell an AI-powered tool for diagnosing coronary artery disease (CAD) on echocardiograms.

The product, EchoGo Pro, was tested and validated in the U.S. as well as at the University of Oxford in England, according to an announcement.

The company will offer it as a module in its EchoGo suite, a cloud-based service that uses AI to automatically supply physicians with algorithmic echocardiography analysis.

Ultromics says EchoGo Pro’s algorithms were trained on large Oxford datasets and can help speed time to appropriate interventions for CAD patients.

It’s now available in the U.S. and European Union, and it’s being assessed at Mayo Clinic.