Reviewed 21 Jul 2026

Completeness Fair (28%)

Paige Breast Lymph Node

Paige

Detects foci that are suspicious for breast cancer metastasis on WSI from lymph node specimens. If concerning morphology is detected, it indicates the foci suspicious for cancer. It is the responsibility of a qualified pathologist to employ appropriate procedures to assure the quality of the images.

Performance: Standalone performance was evaluated with 685 WSI from slides prepared in diverse laboratories, including cancer & benign cases. Cancer cases were enriched for challenging tumors (less than 0.5mm linear extent). Overall sensitivity and specificity were measured as 98% and 85%, respectively. Overall micrometastasis sensitivity was measured as 97.7% and small metastasis sensitivity was 98.9%.

No papers to support — we monitor for new evidence.

General Information

Product name

Paige Breast Lymph Node

Company

Modality

Histopathology

Main task

Detection

Subspeciality

Breast pathology

Organ/Specimen source

Not specified

Disease targeted

Breast cancer

Specimen type

Not specified

Staining

H&E

Stain subtype

Not specified

Regulatory Information

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)

Leica

Scanner Models Certified for Use (CE-IVD)

Not specified

Other certifications

Not specified

Evidence & Research

No research papers or evidence on file yet.

The registry monitors publications for new evidence.

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

Not specified

Based on

Not specified

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

Paige Breast Lymph Node - Paige