FDA qualifies first AI tool to accelerate MASH drug development (Healio)

The FDA has taken a landmark step in drug development by qualifying its first artificial intelligence tool, AIM-MASH AI Assist, to help score liver biopsies in metabolic dysfunction–associated steatohepatitis (MASH) clinical trials. Developed by PathAI, the system uses machine learning to standardize notoriously variable histologic assessments while keeping pathologists firmly in the loop. Experts say the move could cut noise, speed trials, and accelerate much-needed therapies for a growing global liver disease crisis—signaling how AI is beginning to reshape how new drugs reach patients.