First FDA Clearance Issued to Butterfly Network for Gestational Age Estimation Tool

Butterfly Network Inc. has received U.S. Food and Drug Administration (FDA) clearance for a fully automated gestational age (GA) tool integrated into its handheld ultrasound solution. This marks the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age.

Despite its critical importance in guiding pregnancy care, timely, accurate gestational age assessment remains a gap in maternal care worldwide. In the U.S., nearly half of rural counties lack hospital obstetric services, and communities facing socioeconomic barriers have worse outcomes. Globally, 92% of maternal and neonatal deaths occur in low- and middle-income countries—many of which are preventable with access to basic imaging and earlier intervention. In these settings, limited access to ultrasound and trained specialists makes gestational age difficult to establish, particularly in emergent situations where patients may not know or be able to communicate it. Earlier identification enables clinicians to time key prenatal screenings, detect complications sooner, guide intervention, and ultimately improve outcomes for mothers and babies.

“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,” said Sachita Shah, M.D., vice president, Global Health, Butterfly Network. “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.”

Butterfly’s GA Tool builds on deep-learning models developed by Jeffrey Stringer, M.D., and team at the University of North Carolina at Chapel Hill, and uses an artificial intelligence (AI)-powered blind-sweep method to deliver a reliable gestational age estimate in under two minutes through a fully automated, three-step process: enter fundal height, apply gel, and perform guided sweeps. The tool is designed to minimize user variability and deliver rapid insights by eliminating the need for image capture, interpretation, or fetal biometric measurements.

Trained on more than 21 million images across diverse patient demographics and care settings, the model delivers consistent results in patients between 16-37 weeks that are equivalent to sonographer-performed, biometry-based gestational age assessments. The solution is integrated directly into the Butterfly app and can be made available to caregivers worldwide.¹

“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,” Butterfly Chief Business Officer Steve Cashman stated. “Ultimately, it’s about helping clinicians act faster, earlier, and with greater confidence, at critical moments and in any setting.”

Butterfly’s GA tool has already been deployed in Malawi and Uganda, and is made possible in part by a grant from the Gates Foundation. FDA clearance enables expedited pathways to expand across additional regions in sub-Saharan Africa.

Butterfly Network Inc. is a healthcare company striving to drive a digital revolution in medical imaging with its proprietary Ultrasound-on-Chip semiconductor technology and ultrasound software solutions. In 2018, Butterfly launched the world’s first handheld, single-probe, whole-body ultrasound system, Butterfly iQ. The iQ+ followed in 2020, and the iQ3 in 2024, each with improved processing power and performance by leveraging Moore’s Law. The iQ3 earned Best Medical Technology at the 2024 Prix Galien USA Awards. Butterfly’s innovations have also been recognized by Fierce 50, TIME’s Best Inventions and Fast Company’s World Changing Ideas, among other achievements.

Butterfly combines advanced hardware, intelligent software, AI, services, and education to drive adoption of affordable, accessible imaging. Clinical publications demonstrate that its handheld ultrasound probes, paired with Compass enterprise workflow software, can help hospital systems improve care workflows, reduce costs, and enhance provider economics. With a cloud-based solution that enables care anywhere through next-generation mobility, Butterfly aims to democratize healthcare by addressing critical global healthcare challenges. Butterfly devices are commercially available in parts of Africa, Asia, Australia, Europe, the Middle East, North America, and South America.

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¹ Butterfly’s presets, imaging modes and features are not all available everywhere. Check for availability in your country, subscription type, and software version.