STAT+: A ‘historic’ FDA clearance raises the question: Is LLM the interface? Or the decision-maker?

UpDoc, a digital health company, received the first FDA clearance for medical software using patient-facing large language models (LLMs) in its diabetes management app. The app, which helps patients follow doctor-defined treatment plans, uses an LLM-based interface to provide treatment instructions based on user inputs like voice and text.