Find here all our blog posts tagged with: Real-World Evidence.
The Continuous-Update Trap in Medical AI Governance
FDA now lets manufacturers update AI devices without new submissions, but EU's MDR/IVDR and AI Act stack offers no equivalent, forcing a split lifecycle strategy.
Routine Health Data Is Fueling AI Devices Faster Than FDA Can Define the Standard
FDA's December 2025 real-world evidence guidance lets sponsors train AI devices on routine health data, but provenance and bias standards remain undefined.
