AI-assisted cardiac ultrasound guidance software receives De Novo clearance

The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert.

“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool.”