Butterfly Network announced that the U.S. Food and Drug Administration has granted clearance for its new artificial‑intelligence powered ultrasound tool that estimates gestational age. The approval allows the company to offer a fully automated, blind‑sweep gestational‑age (GA) tool integrated into its handheld ultrasound platform, marking the first FDA‑approved blind‑sweep AI application for estimating gestational age.
The tool uses a three‑step process—entering fundal height, applying gel, and performing guided sweeps—to deliver a gestational‑age estimate in under two minutes. It was trained on over 21 million images from diverse patient demographics and care settings, and delivers results that are equivalent to sonographer‑performed, biometry‑based assessments for patients between 16 and 37 weeks.
Butterfly’s clearance expands its product portfolio into maternal‑health imaging and strengthens its position as a semiconductor‑based ultrasound platform. The company’s strategy to transition from a device vendor to a platform provider is reinforced by this regulatory milestone, which could accelerate adoption of its AI‑enabled imaging solutions in clinical practice.
The GA tool is designed to improve access to prenatal care in underserved areas. By automating image acquisition and analysis, the tool can reduce the need for highly trained sonographers and lower the cost of prenatal screening. The company has already deployed the tool in Malawi and Uganda, supported by a $5 million grant from the Bill & Melinda Gates Foundation, and it is expected to help reduce maternal and fetal mortality worldwide.
Management highlighted the strategic significance of the clearance. “Improving maternal health outcomes and expanding access to prenatal imaging has become an urgent priority,” said Sachita Shah, MD, Vice President of Global Health. “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.”
Financially, Butterfly reported a 19% revenue growth in the last twelve months, although the company remains unprofitable due to ongoing investments in product development. The new GA tool is expected to open a new revenue stream and support the company’s broader platform strategy.
The FDA clearance is a significant regulatory achievement that positions Butterfly Network as a leader in AI‑enabled ultrasound technology and expands its reach into global maternal‑health markets.
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