FDA Clears Butterfly Network AI Tool That Estimates Gestational Age From Blind Sweeps

The U.S. Food and Drug Administration has cleared Butterfly Network's Gestational Age Tool, AI software for the company's handheld ultrasound that estimates how far along a pregnancy is from a series of guided "blind" sweeps across the abdomen, Butterfly said on March 30 in a press release. The company said it is the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age.

The FDA's 510(k) records, read through the agency's openFDA database, list the Butterfly Gestational Age Tool as K252148, a traditional 510(k) received on July 9, 2025, and found substantially equivalent on March 27, 2026. It is classified under product code IYN, pulsed Doppler ultrasonic imaging systems.

How the tool works

According to Butterfly, the user enters the patient's fundal height, applies gel and performs guided sweeps with the probe, and the software returns a gestational age estimate in under two minutes. The company said the method removes the need for image capture, interpretation or fetal biometric measurements, which is meant to reduce variability between users.

Butterfly said the model was trained on more than 21 million images from diverse patients and care settings, and that it produces results in pregnancies between 16 and 37 weeks that are equivalent to biometry-based gestational age assessments by sonographers. Diagnostic Imaging reported the same 16-to-37-week range and attributed the equivalence claim to the company. The release did not include accuracy figures.

The tool builds on deep-learning models developed by Jeffrey Stringer and a team at the University of North Carolina at Chapel Hill, the company said. It runs in the Butterfly app and requires an iQ+ or iQ3 probe and an active Advanced membership.

"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," said Sachita Shah, Butterfly's vice president of global health.

Where Butterfly plans to use it

Butterfly's chief business officer, Steve Cashman, said the tool is aimed at three uses: faster decisions in emergency settings when gestational age is unknown, wider access in countries with high maternal and neonatal mortality, and prenatal ultrasound in rural U.S. communities where patients may otherwise travel hours for imaging.

The company said the tool has already been deployed in Malawi and Uganda, supported in part by a grant from the Gates Foundation, and that the clearance will help it expand to other parts of Sub-Saharan Africa. In the U.S., Butterfly pointed to federal rural health transformation initiatives that are driving investment in access to care.

The release cites statistics that nearly half of rural U.S. counties lack hospital obstetric services and that 92% of maternal and neonatal deaths occur in low- and middle-income countries. Butterfly did not give pricing for the feature.