Paige.AI

By Paige.AI
· USA
Paige.AI — Prostate cancer detection support in digital pathology.
Diagnostic
Pathology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
USA
AI type
Diagnostic

Precise indication

Prostate cancer detection support in digital pathology.

Regulatory status

First FDA-cleared digital pathology AI diagnostic aid.

Clinical evidence

Vendor-supported

Not the primary source used here.

Independent

Specialized trade press coverage of the historic FDA clearance.

Real-world deployment

Not quantified in this research pass.

Interoperability

European status

Editorial verdict

Limits and uncertainties

No independent performance study found in this pass, beyond coverage of the regulatory milestone itself.

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
Paige.AI
Headquarters
USA
AI type
Diagnostic
Specialty
Clinical role
Adjunct (decision support)
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 →

Spotted an error?

Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.