Ultrasound AI has received FDA de novo clearance for its Delivery Date AI technology, a cloud-based software as a medical device designed to determine a predicted delivery date from standard ultrasound images.
The tool uses deep-learning neural networks trained on millions of deidentified ultrasound images to analyze fetal and maternal characteristics correlated with delivery timing, according to a March 2 news release from the company. It is intended as an adjunctive tool to aid clinical decision-making in pregnancies where traditional dating methods, including last menstrual period and ultrasound gestational age dating, are unreliable.
The clearance comes as hospitals intensify efforts to improve maternal outcomes amid persistent challenges. The U.S. earned a “D+” grade for its preterm birth rate of 10.4%, and maternal mortality remains elevated at 18.6 deaths per 100,000 live births. Health systems are increasingly deploying AI-driven monitoring tools, navigation programs and early warning systems to reduce complications and expand access to high-risk obstetric care.
With FDA clearance, Ultrasound AI’s technology is now available to practices, hospitals, imaging centers and ultrasound equipment partners.
