FDA clears AI-guided software for capturing cardiac ultrasound images

The Food and Drug Administration has given its clearance to software to help clinicians acquire standard views of the heart from different angles to diagnosis cardiac conditions.

The software—called Caption Guidance—was developed using machine learning and is the first software authorized to guide users through cardiac ultrasound (echocardiography) image acquisition, according to the FDA.

Caption Guidance from medical artificial intelligence vendor Caption Health leverages an interactive AI user interface that guides users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality.


“Echocardiograms are one of the most widely used diagnostic tools in the diagnosis and treatment of heart disease,” says Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, who notes that the marketing authorization of the software “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.”

The FDA evaluated data from two independent studies of Caption Guidance, including a multi-center prospective clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute, which assessed the use of the software by eight registered nurses with no prior ultrasound experience and who were able to acquire echocardiography images and videos of diagnostic quality.

“Point-of-care ultrasound has been demonstrated to expedite time to diagnosis, reduce the need for more costly testing, and decrease complications from invasive procedures,” says John Bailitz, MD, system point of care ultrasound education director at Northwestern Medicine. “Caption Guidance can unlock these benefits by addressing one of the largest barriers to ultrasound adoption—the ability to acquire diagnostic quality images quickly.”

Initially, the software will be used in acute point-of-care settings, including anesthesiology and emergency departments as well as critical care units, according to Caption Health.

Currently, the software can be used with a specific FDA-cleared diagnostic ultrasound system from Teratech, with the potential for use with other ultrasound imaging systems that have technical specifications consistent with the range of systems used as part of the development and testing, according to the regulatory agency.