BURLINGTON, Mass. & NEW YORK — Butterfly Network has received U.S. Food and Drug Administration clearance for an artificial intelligence-powered ultrasound tool that can estimate gestational age in minutes, marking a significant development in prenatal care.
The tool, integrated into the company’s handheld ultrasound system, is the first FDA-cleared blind-sweep ultrasound AI technology designed to determine how far along a pregnancy is without requiring advanced imaging expertise.
The company said the technology addresses a major gap in maternal healthcare, where timely and accurate assessment of gestational age remains a challenge, particularly in rural and underserved regions. In the United States, nearly half of rural counties lack hospital obstetric services, while globally, most maternal and neonatal deaths occur in low- and middle-income countries.
Butterfly’s system uses an AI-driven, three-step process — entering fundal height, applying gel, and performing guided sweeps — to generate a gestational age estimate in under two minutes. The approach eliminates the need for manual image capture, interpretation, or fetal measurements, reducing variability and enabling broader use by non-specialists.
The algorithm was trained on more than 21 million images across diverse patient populations and has demonstrated results comparable to traditional sonographer-performed assessments in pregnancies between 16 and 37 weeks, according to the company.
“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 of global health at 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.”
Company executives said the tool is designed for use in a range of clinical scenarios, including emergency settings where gestational age may be unknown, as well as in regions with limited access to ultrasound equipment or trained specialists.
“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,” said Steve Cashman, chief business officer of Butterfly Network. “Ultimately, it’s about helping clinicians act faster, earlier, and with greater confidence, at critical moments and in any setting.”
