What the research found
Researchers analysed 239 AI-enabled radiology software devices listed in the European Health AI Register and FDA sources. Of these, 128 held a CE mark only, 95 were CE-marked before FDA clearance, and just 16 went the other way. Among dual-authorised devices, CE-first tools waited a median 17.5 months (IQR 8.0 to 35.5) for their second authorisation versus 3.5 months (IQR 1.0 to 11.3) for FDA-first tools, with radiograph-interpretation software waiting longest (hazard ratio 0.42). The authors describe a persistent transatlantic asymmetry and call for greater regulatory coordination and transparency.
The same AI tool can be in routine European use for well over a year before a second regulator has examined it — so where a tool was cleared tells a provider almost as much about the scrutiny behind it as whether it was cleared at all.