Butterfly Network has received clearance from the U.S. Food and Drug Administration (FDA) for a gestational age tool integrated into its handheld ultrasound system.
The tool uses an AI-powered blind-sweep method to deliver a gestational age estimate in under two minutes via a three-step process: entering fundal height, applying gel, and performing guided sweeps, according to the company. It eliminates the need for image capture, interpretation, or fetal biometric measurements, Butterfly said.
Trained on more than 21 million images across a variety of patient demographics and care settings, the model delivers results in patients between 16 and 37 weeks that are equivalent to sonographer-performed, biometry-based assessments, the firm noted.
The tool is integrated into the Butterfly app and has already been deployed in Malawi and Uganda with support from a Gates Foundation grant. FDA clearance enables expanded access across additional regions in sub-Saharan Africa and rural U.S. communities, according to the company.
