Reviewed 9 Jun 2026
Completeness Fair (31%)
Paige Prostate PNI is offered and sold as part of the Paige Prostate Suite.
For use with digitized H&E-stained prostate needle biopsy images. A qualified pathologist should employ appropriate procedures to ensure the quality of the images, and, where necessary, use manual visualization and re-evaluate the product’s result before incorporation into the final diagnosis. The results shall only be considered after a pathologist’s initial review of the entire WSI.
Performance: Validated on a test set of 684 H&E stained prostate needle biopsy images. The dataset included 342 cancer slides (171 with PNI, and 171 without PNI) and 342 benign slides and resulted in an AUC of 0.96, Sensitivity of 91% and Specificity of 88%.
No papers to support — we monitor for new evidence.
General Information
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Regulatory Information
Pathway:
In Vitro Diagnostic Directive (IVDD)
Class:
General IVD Devices
Not verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Scanner Models Certified for Use (CE-IVD)
Not specified
Other certifications
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Evidence & Research
No research papers or evidence on file yet.
The registry monitors publications for new evidence.
Technical Specifications
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Market Presence
On market since
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Pricing Information
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First published: Aug 1, 2025 | Last updated: Jun 9, 2026