Ultrasound AI has received de novo clearance from the U.S. Food and Drug Administration (FDA) for its Delivery Date AI, a cloud-based software as a medical device (SaMD) that predicts fetal delivery date from standard ultrasound images.
The software uses deep-learning neural networks to analyze ultrasound images for fetal and maternal characteristics connected to delivery timing and predict a delivery date, according to the company. It is designed as an adjunctive tool for pregnancies where traditional dating methods, including last menstrual period and ultrasound gestational-age dating, are unreliable, Ultrasound AI said.
Delivery Date AI is compatible with most existing ultrasound machines and is now available to practices, hospitals, and imaging centers across the U.S.
