Public source

Reviewed 21 Jul 2026

Completeness Fair (39%)

Paige Prostate Detect

Paige

Paige Prostate Detect is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.

Supported by 8 papers

General Information

Product name

Paige Prostate Detect

Company

Modality

Histopathology

Main task

Detection

Subspeciality

Uropathology

Organ/Specimen source

Not specified

Disease targeted

Prostate cancer

Specimen type

Biopsy

Staining

H&E

Stain subtype

Not specified

Regulatory Information

FDA Certification

Pathway:

De novo 510(k) cleared

Class:

Class II

FDA Number:

Verified by Health AI Register

CE-IVD Certification

Pathway:

In Vitro Diagnostic Directive (IVDD)

Class:

General IVD Devices

Not verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Not specified

Scanner Models Certified for Use (CE-IVD)

Not specified

Other certifications

Not specified

Technical Specifications

Patient population age

Not specified

Input

Not specified

Input format

Not specified

Output

Not specified

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

Not specified

Viewer systems

Not specified

Market Presence

On market since

Not specified

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Subscription

Based on

Not specified

Source: Public | First published: Aug 1, 2025 | Last updated: Jul 21, 2026