FDA-cleared
The mammography AI we start with is already FDA-cleared — 510(k) K252954
€0
Cost to the health service to evaluate it
4 phases
A staged path — start tiny, grow only if it earns trust
#1
Breast is the most-diagnosed cancer — where screening volume is highest
5
EU rules the platform is built to satisfy (GDPR, AI Act, EHDS, MDR, NIS2)
2 regions
Madrid first, Andalucía in parallel — both already investing in cancer-screening AI
Two regions, one safe starting point: a cleared imaging engine, wrapped in a governed platform, on a path a public health system can actually trust.