Two regulatory milestones arrived for clinical software this week: the FDA granted De Novo clearance to Ultrasound AI’s cloud‑based Delivery Date AI that predicts delivery date from standard ultrasound images, and Italian bioinformatics firm EnGenome obtained EU IVDR Class C certification for its eVai variant interpretation platform. Ultrasound AI’s De Novo status enables broader U.S. commercialization of an obstetrics SaMD, while EnGenome’s IVDR certification formalizes the platform’s quality systems for variant interpretation in the EU clinical market.