Butterfly Network said on Monday it received U.S. regulatory clearance for an artificial intelligence-powered ultrasound tool that can estimate gestational age, a move the company said could expand access to maternal care in underserved areas.
Unlike traditional ultrasound machines that rely on expensive piezoelectric crystals, Butterfly’s device uses a single silicon chip for whole-body imaging. The AI tool delivers an estimate in under two minutes without requiring users to capture or interpret images or perform fetal biometric measurements, the company said.
The model was trained on more than 21 million ultrasound images from diverse patient populations and clinical settings, and is designed to provide consistent results for pregnancies between 16 and 37 weeks.
The clearance comes as the U.S. Food and Drug Administration encourages the use of artificial intelligence in medical devices. The FDA says on its website that AI and machine learning have the potential to improve healthcare by generating new insights from data produced during care delivery.
Butterfly said the tool is integrated into its app and is intended to help clinicians make faster decisions in emergency departments, rural clinics and other low-resource settings.
The company said gaps in access to prenatal imaging remain significant, noting that many rural U.S. counties lack hospital obstetric services.
Butterfly also said the tool has already been deployed in Malawi and Uganda, and that it plans to expand its use in the U.S. and other international markets.