New Ultrasound AI Tool Supports Rapid Prenatal Assessment

Access to ultrasound and trained sonographers is uneven, with nearly half of U.S. rural counties lacking hospital obstetric services and most maternal and neonatal deaths occurring in low- and middle-income countries. Rapid, consistent methods are especially needed in emergencies and resource-constrained settings. A new system now offers an FDA-cleared, AI-driven blind-sweep approach that estimates gestational age in under two minutes.

Butterfly Network’s fully automated Gestational Age (GA) Tool is now integrated into its handheld ultrasound solution, marking the first U.S. Food and Drug Administration (FDA)-cleared blind-sweep ultrasound artificial intelligence (AI) application for estimating gestational age. Embedded directly within the Butterfly app, the tool is designed to streamline point-of-care workflows by enabling rapid, standardized assessments without the need for advanced ultrasound expertise.

The GA Tool uses an AI-driven blind-sweep approach to generate gestational age estimates through a simple three-step process: enter fundal height, apply gel, and perform guided sweeps. By removing the need for image capture, interpretation, and fetal biometric measurements, the system reduces user variability while delivering results in under two minutes. The underlying model builds on deep-learning research developed at the University of North Carolina at Chapel Hill, further supporting its clinical reliability and real-world applicability.

Trained on more than 21 million images spanning diverse patient demographics and care settings, the system produced consistent results in pregnancies from 16 to 37 weeks that were equivalent to sonographer-performed, biometry-based assessments. The tool has already been deployed in Malawi and Uganda and is supported in part by a grant from the Gates Foundation. The announcement also underscores persistent access gaps that the technology is intended to address across emergency care, rural U.S. communities, and regions with high maternal and neonatal mortality.

“Improving maternal health outcomes and expanding access to prenatal imaging has become an urgent priority, and Butterfly is proud to be the first to bring this type of technology to mothers globally. 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, MD, Vice President, Global Health, Butterfly Network.

“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, where patients may otherwise travel hours for imaging. Ultimately, it’s about helping clinicians act faster, earlier, and with greater confidence, at critical moments and in any setting,” said Steve Cashman, Chief Business Officer, Butterfly Network.

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