The FDA granted De Novo clearance to Ultrasound AI’s cloud‑based Delivery Date AI software-as‑a‑medical‑device, allowing obstetric providers to use standard ultrasound images to predict delivery date. The classification establishes a regulatory pathway for similar algorithmic obstetric tools and permits commercial deployment under specified conditions. Ultrasound AI’s SaMD integrates into clinical workflows and aims to improve dating accuracy where LMP or other measures are uncertain. The clearance will prompt medical centers to evaluate operational integration, data security, and clinician oversight standards for AI‑driven obstetric decision support. De Novo clearance signals the FDA’s ongoing willingness to vet and authorize AI tools that augment clinical assessment when validated against relevant clinical endpoints and accompanied by appropriate labeling.