How does the FDA-cleared Delivery Date AI technology work? Raquel Dardik, MD, explains

Following the FDA De Novo clearance of Delivery Date AI, Raquel Dardik, Chief medical officer, Ultrasound AI; Clinical associate professor, OBGYN, Herbert Wertheim College of Medicine, explained that the technology functions as a form of "precision medicine" by analyzing ultrasound images at a level of detail beyond human perception. Unlike traditional biometry, which focuses on specific fetal measurements, the AI utilizes convolutional neural networks to evaluate the entire image.¹

“The AI looks at the entire image. So it doesn't look at just one thing, it takes the full image,” Dardik said. She noted that clinicians can view heat maps on the back end to see which structures the AI prioritized for a specific predicted delivery date (PDD).

“In one area, it may be looking at the placenta and the cervical length; at another time, it may be looking at the endometrium, the uterus, and the ovaries. So it is a very active, precision kind of medicine, not just the standard.

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The clinical necessity for such a tool is underscored by the high rate of preterm births occurring in patients previously considered low-risk. While the PAIR study demonstrated a high predictive accuracy with an R² value of 0.92, Dardik emphasized that the tool is intended to augment, not replace, physician judgment. She compared the innovation to the introduction of ultrasound itself, which replaced the fetoscope.

“Ninety percent of preterm deliveries are in low-risk women, and so we're missing a whole host of options and possibilities that we could perhaps optimize if that were the case,” Dardik said. By predicting early delivery, clinicians can ensure patients are closer to level 3 NICUs or tertiary care centers, which is particularly vital in "medical care deserts" where high-risk obstetricians are scarce.

Regarding the regulatory status, Dardik highlighted the significance of the De Novo pathway. Unlike a 510(k) clearance, which compares a device to an existing predicate, De Novo clearance is reserved for novel technologies.

“There is no comparable technology, and we have nothing to base a comparison on. So you have to prove from the start what this technology is and how it works,” Dardik explained. “The FDA clearly feels that this technology is going to advance women's health, and therefore, was granted De Novo clearance.”

References:

1. Fitch J. Ultrasound AI receives De Novo clearance for predictive delivery date technology. Contemporary OB/GYN. Published March 2, 2026. Accessed March 4, 2026. https://www.contemporaryobgyn.net/view/ultrasound-ai-receives-de-novo-clearance-for-predictive-delivery-date-technology
2. Fitch J. Raquel Dardik, MD, explains Ultrasound AI's FDA-cleared delivery date technology. Contemporary OB/GYN. Published March 3, 2026. Accessed March 4, 2026.