AI-powered BCI regulation and reimbursement move toward formal infrastructure

China's first reported medical-device standard dedicated to AI-powered BCIs takes effect in September 2027 and addresses EEG dataset collection, annotation, storage, access, and quality testing. Separately, Neuracle's reported NMPA approval and insurance-code adoption within 48 hours highlight reimbursement and industrial coordination as adoption drivers; privacy, bias, transparency, independent validation, and enforcement remain unresolved.