FDA Issues De Novo Clearance of Ultrasound AI Software for Delivery Date Prediction
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
A 2025 study of the Delivery Date AI software, published in the
"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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