In this session, leaders from Floreo, a VR system for teaching skills to neurodiverse children, and Cortica, the leading provider of whole-child value-based autism care, will describe their strategy and partnership as Floreo seeks FDA approval as a medical device. In 2023 after concluding a pilot study together, Floreo gained FDA Breakthrough Device Designation on the basis of the outcomes data generated. In this session, the trial design and regulatory strategy of both the pilot study and upcoming pivotal trial will be detailed, including tips specific to XR applications based on FDA guidance.