First AI-Guided Ultrasound Gets Green Light From FDA

Caption Health, a company based outside of San Francisco, CA, won the first authorization from the FDA for an ultrasound software that guides clinicians at capturing images of the heart. The Caption Guidance software should work with any number of ultrasound system from different manufacturers, but currently it can only be used with a diagnostic ultrasound from Terason, of Burlington, MA, a part of Teratech Corporation.

As part of the De Novo premarket review that the Caption Guidance software went through, an interesting study was conducted in which eight registered nurses, with little experience in sonography, used the software to help them produce echocardiography images. According to a team of cardiologists that viewed these, the images were of substantially high quality to use for diagnostics.

“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in an announcement. “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. This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”

Caption Health claims that its software allows just about anyone, even with zero ultrasound experience, to acquire high quality images of the heart. This should allow clinics to have more freedom to utilize clinicians in a varied way, allowing some to do things they would not be able to do without such software. The company expects that emergency rooms, critical care units, and anesthesiology departments will be where Caption Guidance will see the most use.


An apical two-chamber view of the heart captured by Caption AI.

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