Caption Health gains FDA clearance for AI-powered ejection fraction software

Caption Health has received FDA clearance for the latest version of its AI-powered ejection fraction (EF) assessment software.

The software, Caption Interpretation, uses deep learning technology to scan ultrasound exams, identify the most helpful clips it can find and provide high-quality EF measurements. It uses three ultrasound views in all to complete each assessment, taking “every pixel and frame” of each selected clip into account.  

The original Caption Interpretation software first gained FDA clearance in 2018. This updated version, Caption Health has said, is more user-friendly.  

“We are pleased to have received FDA clearance for our latest AI imaging advancement—our third so far this year,” Randolph P.  Martin, MD, chief medical officer of Caption Health and a professor at Emory University School of Medicine, said in a statement. “An accurate EF measurement is an indispensable tool in a cardiac functional assessment, and this update to Caption Interpretation makes it easier for time-constrained clinicians to incorporate it into their practice.”

“Developing AI that mimics an expert physician's eye with comparable accuracy to automatically calculate EF—including from the parasternal long-axis view, which has never been done before—is a major breakthrough,” added Roberto M. Lang, MD, a professor at the University of Chicago Medicine and past president of the American Society of Echocardiography. “Whether you are assessing cardiac function rapidly, or looking to monitor changes in EF in patients with heart failure, Caption Interpretation produces a very reliable assessment.”