The U.S. FDA has announced its marketing authorization for the first AI-enabled cardiac ultrasound software. Developed by Caption Health, the Caption Guidance tool uses AI to help medical professionals capture images for heart disease diagnostic tests without the assistance of an ultrasound expert.
“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
The agency says the software is now approved for use in adult patients for the acquisition of standard views of the heart from different angles. It’s currently compatible with a Teratech Corporation-produced diagnostic ultrasound system, and has the potential to be used with other ultrasound imaging systems with similar specifications.
In its review of this device application, the FDA said, it evaluated data from two independent studies. “In one study, 50 trained sonographers scanned patients, with and without the assistance of the Caption Guidance software. The sonographers were able to capture comparable diagnostic quality images in both settings. The other study involved training eight registered nurses who are not experts in sonography to use the Caption Guidance software and asking them to capture standard echocardiography images, followed by five cardiologists assessing the quality of the images acquired. The results showed that the Caption Guidance software enabled the registered nurses to acquire echocardiography images and videos of diagnostic quality.”
The tool’s initial deployment will be in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, with plans to expand to additional departments. According to the CDC, heart disease, a term that refers to several types of heart conditions, is the leading cause of death in the United States, killing one out of every four people, or approximately 647,000 Americans each year. The settings designated for initial deployment serve a high volume of patients, with emergency rooms alone visited by one in five U.S. adults at least once per year.