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News|Videos|March 2, 2026

FDA Issues De Novo Clearance of Ultrasound AI Software for Delivery Date Prediction

Author(s)Jeff Hall

Offering reportedly seamless integration into workflows for prenatal evaluations and real-time decision-making, the cloud-based Delivery Date AI software was trained on millions of ultrasound images from diverse pregnancies.

The Food and Drug Administration (FDA) has granted De Novo clearance for Delivery Date AI, a cloud-based software that utilizes AI to help predict delivery dates based on standard ultrasound images.

Powered by deep learning neural networks for ultrasound image assessment, the Delivery Date AI software was trained on millions of ultrasound images across diverse pregnancies and health-care settings, according to Ultrasound AI, the developer of Delivery Date AI.

A 2025 study of the Delivery Date AI software, published in the Journal of Maternal-Fetal and Neonatal Medicine, revealed an R2 value of 92 percent for preterm birth prediction.

"Fetal development and delivery timing impact nearly every decision in obstetrics," said Nathan Fox, M.D., board-certified OBGYN, maternal fetal medicine specialist, and partner physician with Ultrasound AI. "Delivery Date AI gives clinicians unprecedented insight into a pregnancy's progression, allowing us to make more informed decisions for how and when we intervene. This technology has transformative implications for maternal and fetal health care."

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