Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base

The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.

Ultrasound machine in a modern operating laboratory.

Software that helps health care professionals capture high-quality ultrasound images of patients’ hearts has won marketing clearance from the US Food and Drug Administration in what the agency says is the first authorization for that device type.

Caption Health’s Caption Guidance software is used during heart imaging – also known as two-dimensional transthoracic echocardiography – to...