FDA authorizes AI-powered cardiac ultrasound guidance software

Caption Health, a California-based AI company, has received authorization from the FDA to market its software solution for acquiring echocardiography images in the United States. The Caption Guidance software uses AI to help healthcare providers image a patient’s heart, even when they have no prior experience with ultrasound technology.

“We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine” Charles Cadieu, co-founder and president of Caption Health, said in a prepared statement. “This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we're just getting started.”

The FDA released a separate statement of its own about this announcement, noting that the software is indicated for use on adult patients, “specifically in the acquisition of standard views of the hart from different angles.” Caption Guidance is to be operated with a specific ultrasound system produced by Teratech Corporation, but the FDA noted there is potential for it to be used “with other ultrasound imaging systems that have technical specifications consistent with the range of ultrasound systems used as part of the development and testing.”

“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, PhD, deputy director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health. “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.”

Two independent studies were reviewed by the FDA as it reached its decision to authorize this software. While one study involved 50 specialists scanning patients with and without assistance from Caption Guidance, another study involved training eight nurses “who are not experts” to use the software.

The FDA reviewed and authorized this solution through the De Novo premarket review pathway.