Butterfly Network announced on Monday that it has received U.S. regulatory clearance for its AI-powered ultrasound tool, which can estimate gestational age. The company said this approval could help expand access to maternal care in underserved regions.
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.
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The AI model was trained on over 21 million ultrasound images from a wide range of patient populations and clinical environments, aiming to deliver reliable results for pregnancies between 16 and 37 weeks.
The clearance comes amid the U.S. Food and Drug Administration’s push to encourage the use of artificial intelligence in medical devices. According to the FDA, AI and machine learning can enhance healthcare by generating new insights from data collected during care.
Butterfly Network said the tool is integrated into its app and is designed to help clinicians make faster decisions in emergency rooms, rural clinics, and other resource-limited settings.
