FDA greenlights AI tool to help novices obtain heart ultrasound images

The U.S. Food and Drug Administration has given its blessing to begin marketing of a new artificial intelligence tool that aids clinicians in the acquisition of cardiac ultrasound images.

Caption Guidance, as it’s called, serves as an accessory with diagnostic ultrasound systems, helping to capture high-quality images of patients’ hearts. It’s indicated for use in two-dimensional transthoracic echocardiography for adult patients, and can aid in diagnosing various heart conditions, the FDA said in a Feb. 7 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,” Robert Ochs, PhD, deputy director of the Office of In Vitro Diagnostics and Radiological Health, said in a statement. “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.”

FDA officials noted that Caption Guidance is the first program authorized to guide individuals through acquisition of ultrasound images. The software was developed by Caption Health Inc., using machine learning to recognize, in real time, when heart scans are of acceptable quality.

Caption Guidance can currently be used with the FDA-cleared ultrasound system produced by Teratech Corporation, or other ultrasound imaging systems that have similar technical specifications.

The administration based its approval is based on two independent studies. In one instance, eight registered nurses with no expertise in sonography used the software to capture heart images. Five cardiologists then assessed the scans, and determined they were of high enough quality for diagnostic use, according to the FDA.