Cancer detection in digital pathology (prostate, extended to breast and gastric).
Regulatory status
Galen Prostate is the first standalone AI-powered cancer diagnostics solution to obtain CE-IVD marking under the IVDR; extensions to breast and gastric confirmed.
Clinical evidence
Vendor-supported
Vendor press release for the CE-IVD marking.
Independent
Deployment agreement with Unilabs (a major independent European laboratory network) plus participation in the UK PathLAKE program — two real, named, independent deployment/validation channels.
Real-world deployment
Deployment confirmed via Unilabs (European lab network) and the UK PathLAKE program.
Interoperability
European status
Editorial verdict
Limits and uncertainties
As a standalone (autonomous) diagnostic tool, the pathologist oversight/accountability model should be explained clearly.
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.