Butterfly Network gets FDA clearance for AI gestational age ultrasound tool

Butterfly Network Inc. (NYSE: BFLY) received U.S. Food and Drug Administration clearance for an automated gestational age tool integrated into its handheld ultrasound device, the company announced. The approval marks the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age.

The AI-powered tool uses a three-step process to deliver gestational age estimates in under two minutes: entering fundal height, applying gel, and performing guided sweeps. The system eliminates the need for image capture, interpretation, or fetal biometric measurements.

The tool was trained on more than 21 million images across diverse patient demographics and care settings. It delivers results for patients between 16-37 weeks that are equivalent to sonographer-performed, biometry-based gestational age assessments, according to the company.

The technology builds on deep-learning models developed by Jeffrey Stringer and his team at the University of North Carolina at Chapel Hill. The tool has already been deployed in Malawi and Uganda through funding partially supported by the Gates Foundation.

"The GA Tool is built to address three critical use cases: enabling faster decisions in emergency settings when gestational age is unknown; expanding access in countries where maternal and neonatal mortality remains high; and improving prenatal ultrasound access in rural U.S. communities," said Steve Cashman, Butterfly's Chief Business Officer.

Butterfly Network develops semiconductor-based ultrasound devices and software solutions. The company launched its first handheld ultrasound system in 2018, followed by updated versions in 2020 and 2024.

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