Vara wins world’s first CE mark for AI that clears mammograms alone

Vara, a Berlin-based company, received the world's first CE mark for AI that autonomously clears normal mammograms without radiologist review in organized breast cancer screening programs. The AI system, supported by a safety monitoring layer called ATMON, continuously tracks performance and reverts to full radiologist reading if needed. This certification addresses workforce shortages and rising screening demands by allowing AI to handle about 97% of normal cases independently.