Innovating with intelligence: navigating artificial intelligence (AI) medical devices from code to care

In this article, we explore why so many AI‑powered diagnostics and decision‑support tools may stall after regulatory clearance. By tracing the feedback loop between evolving rules, payment incentives, and clinician‑patient confidence, we discuss how each barrier reinforces the next. Despite hurdles, a practical route forward does exist for AI medical devices: harmonised guidance, value‑based financing, and design principles that make algorithms transparent may all facilitate the latest AI innovations in travelling from code to care.