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UNC’s AI-Enabled Ultrasound Gains FDA Clearance to Enhance Maternal Healthcare Access

UNC’s FDA-cleared AI-enabled ultrasound technology revolutionizes maternal healthcare by enabling accurate fetal age estimation without expert interpretation, enhancing access in underserved areas.

April 17, 2026 — The Department of Obstetrics and Gynecology at the University of North Carolina (UNC) announced that its physicians have developed a groundbreaking artificial intelligence–enabled ultrasound technology that has received clearance from the U.S. Food and Drug Administration (FDA). This innovation marks a significant advancement in obstetric care, particularly in resource-limited settings.

Invented by Dr. Jeffrey Stringer, an adjunct professor in the Department of Epidemiology, along with collaborators Ben Pokaprakarn, PhD ’22 (biostatistics), and Juan Prieto, PhD, the new technology allows for the estimation of fetal gestational age from standardized “blind sweep” ultrasound videos. This capability eliminates the need for expert image acquisition or interpretation, thereby streamlining the process of pregnancy dating.

The technology has been licensed to Butterfly Network, which has integrated it into its ultrasound platform. This potential to democratize access to essential obstetric services comes as the healthcare community faces challenges related to the availability of trained sonographers and specialized imaging techniques. The innovation is designed to facilitate accurate pregnancy assessments in areas where conventional ultrasound services are either limited or entirely absent.

Dr. Stringer commented on the significance of this development: “This milestone reflects years of work to rethink how obstetric ultrasound can be delivered. Our goal has been to decouple image acquisition from interpretation, making high-quality obstetric assessment accessible far beyond traditional care settings.”

This underlying technology, developed at UNC, is already in research use across 12 countries and has been supporting global maternal health initiatives in environments constrained by resources. With FDA clearance, the technology is poised for clinical deployment in the United States, particularly in rural and underserved areas identified as maternity care deserts.

The introduction of this AI-enhanced ultrasound technology is expected to fill critical gaps in healthcare delivery, underscoring UNC’s commitment to advancing translational research. As Dr. Stringer noted, the goal is to ensure that effective obstetric care is available to all, regardless of their geographic or socioeconomic status.

The innovation not only enhances the capabilities of ultrasound technology but also bolsters the ability of healthcare providers to offer timely and accurate assessments, potentially improving pregnancy outcomes. As healthcare systems globally strive to enhance maternal health, the successful integration of AI tools like this one could be transformative.

With this regulatory clearance, the landscape of obstetric care may change significantly, offering a more equitable approach to maternal health, especially in areas where women have historically faced challenges in accessing quality care. As the technology continues to evolve, its impact on maternal health around the world will be closely monitored by both healthcare professionals and policymakers.

For further information on this technology and its implications for global health, contact the UNC Gillings School of Global Public Health communications team at [email protected].

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