New AI-based ultrasound echo imaging software authorized by FDA

In a bid to improve cardiovascular care, the Food and Drug Administration has authorized marketing of AI software that helps clinicians acquire diagnostic images.

The software—Caption Guidance—is produced by Brisbane, California-based Caption Health, and works in conjunction with a cardiac ultrasound system to improve heart examinations. In adult patients, the software can acquire standard views of the organ from different angles to produce 2D transthoracic echocardiography images.

“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, a director in the FDA’s Center for Devices 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.”

According to the FDA, this is the first software authorized to guide users through cardiac ultrasound image acquisition. The platform’s AI interface offers real-time feedback on image quality, can automatically capture video clips and intuitively saves the best clip from specific views. Cardiologists can also still look at the images for a final patient assessment.

The administration combed through two independent studies before making its authorization. One showed that sonographers were able to capture similar-quality diagnostic images with and without Caption Guidance. The other enabled registered nurses to acquire high-quality echo images and videos.

Going forward, the FDA noted that this software has the potential to be used with other ultrasound imaging systems that have the required technical parameters.