Butterfly Network said on Monday it had received U.S. regulatory clearance for an AI ultrasound gestational age tool, a development the company says could widen access to maternal care in underserved communities. The company said the tool can estimate gestational age in under two minutes.
Unlike traditional ultrasound systems that depend on expensive piezoelectric crystals, Butterfly’s device uses a single silicon chip for whole-body imaging. The company said the new tool does not require users to capture or interpret images or carry out fetal biometric measurements.
Butterfly said it trained the model on more than 21 million ultrasound images from diverse patient populations and clinical settings. The company designed it to deliver consistent results for pregnancies between 16 and 37 weeks.
The company also said it has integrated the tool into its app to help clinicians make faster decisions in emergency departments, rural clinics and other low-resource settings. That support could prove significant in places where many patients still lack access to prenatal imaging.
Butterfly said major gaps in prenatal imaging persist, noting that many rural U.S. counties lack obstetric services at hospitals. The company said the newly cleared tool could help address some of those access challenges.
It also said the technology has already been deployed in Malawi and Uganda, with plans to expand its use across the United States and other international markets.
The clearance comes as the U.S. Food and Drug Administration has encouraged the use of artificial intelligence in medical devices. According to the FDA information cited in the source, AI and machine learning can improve healthcare by generating new insights from data created during care delivery.
