FDA Clears AI-Powered Ultrasound Tool That Determines Gestational Age in Minutes

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Gestational Age tool, an ultrasound-based AI model that may enable automated fetal age assessments between 16 and 37 weeks.

Butterfly Network, the developer of the AI-powered modality, said the Gestational Age tool was trained on over 21 million images and provides gestational age assessments that are equivalent to those of biometry-based assessments by sonographers.

After a three-step blind sweep method that incorporates fundal height and guided ultrasound sweeps, Butterfly Network said the Gestational Age tool, available through the Butterfly Network app, supplies age estimates in less than two minutes.

“With FDA clearance, we now have an AI-powered tool that can help transform maternal health, both worldwide and here in the U.S., by addressing longstanding gaps in access to timely, reliable imaging and enabling earlier, more informed care.,” noted Sachita Shah, M.D., vice president of global health at Butterfly Network.