Breast cancer screening (mammography, extended to 3D tomosynthesis).
First CE-marked fully autonomous AI for breast cancer screening in Europe; CE mark extended to 3D tomosynthesis.
Trade press coverage of the CE mark, based on vendor announcement.
Not found in this research pass — verify before publishing.
Deployment within German screening programs claimed by the vendor; exact figures not found in this pass.
As with ChestLink, the autonomous clinical-governance model needs explicit explanation on the public profile.
This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate
Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.
A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.
Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.