Digital pathology
Paige
Assists pathologists in detecting areas suspicious for cancer in digitized prostate needle biopsy slides.
Designed for
Pathologist
Care setting
Pathology laboratory
Specialty
Pathology, Urologic oncology
Our assessment
Paige Prostate has a strong regulated reader-assistance evidence base showing that pathologist performance can be studied with and without AI. The evidence supports an assistive role under the defined workflow more clearly than broad claims across every scanner, laboratory, variant, or later version.
Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.
What the evidence supports
Reviewed regulatory and study sources support adjunctive cancer detection in the defined digital prostate biopsy workflow.
What remains uncertain
Current-version performance across scanners, laboratories, rare morphologies, and changing case mix requires local confirmation.
How it was studied
The FDA De Novo review includes standalone testing and a pathologist reader study comparing performance with and without Paige Prostate. The intended workflow keeps the pathologist responsible for the primary review before activating the AI result.
Product facts
Sources reviewed
3 public sources represented in this evidence profile.
Evidence source base
FDA-reviewed developer-sponsored evidence and published supporting work. Local laboratory and scanner validation remain essential.
Important limitation
A controlled reader study does not establish performance across every scanner, stain, laboratory process, rare variant, current version, or long-term diagnostic workflow.
Questions to ask