Vara has received CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening, the first breast imaging AI certified to report screening examinations as normal without radiologist review. Under this deployment mode, examinations the system classifies as clearly normal can be reported by AI alone; every other examination continues to be read by at least one radiologist.
The timing matters. National screening programmes across Europe are under growing pressure from radiologist shortages, ageing populations, and expanded age ranges for screening, all while every mammogram in double-reading programmes still needs two sets of expert eyes. By taking the clearly normal cases off radiologists' plates, autonomous triage is designed to free up capacity for the cases that genuinely need a specialist's judgement, rather than adding another tool for radiologists to work alongside.
It also marks a shift in how the field talks about AI. For years, the message has been that AI supports the radiologist rather than replacing them. This certification shows that, for some parts of the workflow, that line is starting to move.
Letting AI operate without a radiologist reviewing every case only works if something is watching the AI itself. Vara has put forward their own monitoring tool for this called ATMON: a real-time system that sets and monitors each site's operating point, tracks mammography hardware and system performance, and reverts a site to full radiologist reading whenever predefined limits are exceeded. This kind of continuous human oversight will be essential to bring this way of working to real screening practice.
Vara's certification is not an isolated case. Several other studies, also with other AI solutions, are running across Europe right now into partly autonomous AI in mammography screening, suggesting the field as a whole is taking steps in this direction.
Still, regulatory approval is not the same as regulatory permission to deploy. Most countries do not yet allow the stand-alone use of AI in mammography screening, so direct implementation of Vara's certified workflow may have to wait on national policy before it can reach real screening programmes. Even so, the momentum building around autonomous triage is hard to miss. The moment when this way of working becomes standard practice may not be far off.
