Shionogi launched ENDEAVORRIDE in Japan on June 5, 2026 after Japanese regulators reviewed local and US clinical data. The company also holds Taiwan rights, but APPI News could not verify a Taiwan license or public filing.
The US Food and Drug Administration announced its first TEMPO participant on July 22, 2026 and now lists two manufacturers in the pilot. Their devices can enter Medicare-supported care through conditional enforcement discretion and real-world data collection, not a finding of effectiveness for the uses under review.
Oregon enacted an AI companion law in 2026 that requires crisis protocols and allows harmed users to sue. Illinois, Nebraska, Tennessee and Maine have taken different approaches, leaving the rules dependent on a product's claims, design and users.
A coalition of US state attorneys general reportedly opened an investigation into OpenAI on June 12, 2026, seeking records on advertising, data practices and vulnerable users. The subpoena arrived four days after OpenAI disclosed a confidential draft S-1, but neither the filing nor the subpoena is public.
US regulators updated two software policies in January 2026, clarifying when low-risk wellness products and some clinical decision-support functions fall outside full device oversight. Taiwan requires qualifying AI medical software to enter its device-registration system, while the European Union layers high-risk AI obligations onto existing product rules.
