Ibex Medical Analytics

By Ibex Medical Analytics
· Israel
Ibex Medical Analytics — Cancer detection in digital pathology (prostate, extended to breast and gastric).
Diagnostic
Pathology
Production
CE Marked
Regulatory status
CE Marked
Deployment
Production
Clinical role
Autonomous (decision without systematic review)
Headquarters
Israel
AI type
Diagnostic

Precise indication

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.

Sources

https://www.prnewswire.com/news-releases/ibexs-galen-prostate-becomes-first-standalone-ai-powered-cancer-diagnostics-solution-to-obtain-ce-mark-under-the-ivdr-301743047.html

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

At a glance
Vendor
Ibex Medical Analytics
Headquarters
Israel
AI type
Diagnostic
Specialty
Clinical role
Autonomous (decision without systematic review)
CE marking
Notified body
EU AI Act
Data hosting
Last verified
Reviewed by
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.

Read the methodology →

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