Butterfly Network Wins FDA Clearance for First Blind-Sweep AI Tool to Estimate Gestational Age

Butterfly Network has received U.S. Food and Drug Administration (FDA) clearance for a fully automated, AI-powered tool that estimates gestational age using blind-sweep ultrasound—marking the first clearance of its kind and a notable advance in maternal health.

Integrated into Butterfly’s handheld ultrasound platform, the new Gestational Age (GA) Tool delivers an estimate in under two minutes through a simple three-step process: entering fundal height, applying gel, and performing guided sweeps. The system eliminates the need for image capture, interpretation, or fetal biometric measurements, aiming to reduce variability and expand usability across care settings.

Accurate gestational age assessment is critical for guiding prenatal care, yet remains a major global gap. In the U.S., nearly half of rural counties lack hospital obstetric services, while globally, 92% of maternal and neonatal deaths occur in low- and middle-income countries—many of which are preventable with earlier intervention.

The AI model, developed with researchers at the University of North Carolina at Chapel Hill, was trained on more than 21 million images across diverse populations. It provides estimates for pregnancies between 16 and 37 weeks with accuracy comparable to traditional sonographer-performed biometry.

“Improving maternal health outcomes and expanding access to prenatal imaging has become an urgent priority,” said Sachita Shah, MD, Vice President of Global Health at Butterfly. “With FDA clearance, we now have an AI-powered tool that can help transform maternal health… by enabling earlier, more informed care.”

Butterfly says the tool is designed for three key use cases: rapid decision-making in emergency settings when gestational age is unknown, expanding access in high-mortality regions, and improving care in rural U.S. communities where patients may travel long distances for imaging.

“The GA Tool is about helping clinicians act faster, earlier, and with greater confidence,” added Chief Business Officer Steve Cashman.

The technology has already been deployed in Malawi and Uganda, supported in part by the Gates Foundation. FDA clearance is expected to accelerate expansion into additional regions, including Sub-Saharan Africa, as well as support broader adoption in underserved areas of the United States.