FDA Authorizes Caption Health’s AI System for Cardiac Ultrasounds

The FDA granted marketing authorization for Caption Health’s Caption Guidance, an AI-based software product used to capture images of cardiac ultrasounds.

The imaging software can be used by healthcare providers — even those with no ultrasound experience — to capture diagnostic quality images. It is the first software of its kind authorized for obtaining medical images using real-time AI guidance.

“The software emulates the guidance that an expert sonographer would provide to optimize the image, including providing real-time guidance on how to manipulate the transducer, and automated feedback on diagnostic image quality,” Caption Health said.