Ultrasound AI Gains FDA Clearance For Delivery-Date Tool

Ultrasound AI announced today that it received FDA De Novo clearance for Delivery Date AI, a cloud-based SaMD that predicts a Predicted Delivery Date (PDD) from standard ultrasound images in real time. Trained on millions of de-identified images and evaluated in a peer-reviewed PAIR study of more than 5,700 patients (R² = 0.92), the tool integrates with existing OB/MFM workflows and is now available across the United States.