The sequence changed the wait
The median difference was 14 months among devices that eventually held both authorizations. That is a large operational gap for developers planning launch and for health systems comparing products across markets.
The study used time-to-event methods and reports associations, not a causal ranking of regulators. Differences in classification, submission strategy, evidence, and product type may contribute to the observed sequence.
Coordination should improve evidence portability
Regulators can publish clearer mappings between requirements, accept reusable evidence where appropriate, and explain why additional testing is necessary. Developers should disclose authorization dates, jurisdictions, device versions, and the clinical evidence attached to each decision.
The goal is not the fastest stamp. It is a transparent path that reduces waste, helps hospitals compare like with like, and preserves the independent scrutiny patients expect from each jurisdiction.
Go to the source
Read the evidence behind this analysis. External links open in a new tab.
npj Digital Medicine — Transatlantic approval delays for radiology AI
