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Key Features

  • Cancer detection
  • Cell classification
  • HER2 score
  • Tissue segmentation

General Information

Product name

Mindpeak Breast HER2 RoI

Subspeciality

Breast

Modality

Histopathology

Disease targeted

Breast cancer

Main task

Not specified

Specimen type

Not specified

Staining

IHC

IHC marker used

HER2

Technical Specifications

Population

Not intended to be used for non-cancer breast tissue, necrotic tissue, ductal carcinoma in situ (DCIS) only lesions, inflammatory breast cancer (IBC), angiosarcoma of the breast, Paget disease of the breast, special type carcinoma other than ILC, adenoid cystic carcinoma, low-grade adenosquamous carcinoma, medullary carcinoma, mucinous (or colloid) carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, micropapillary carcinoma, mixed carcinoma

Patient population age

Not specified

Input

whole slide image, 0.5 µm/pixel, ER or PR IHC staining

Input format

BIF, MRXS, NDPI, Others, SVS, TIFF

Output

Cell classification, Image Annotations, Clinical Score, Cell Count

Output format

JSON

Integration

Integration via AI marketplace or distribution platform, Integration with hospital reporting system, Integration with IMS (Image Management System), Integration with LMS (Laboratory Management System)

Deployment

Cloud-based, Hybrid solution, Locally on dedicated hardware, Locally virtualized (virtual machine, docker)

Trigger for analysis

Automatically, Image upload, On demand, Right after the image acquisition, Triggered by a user through e.g. a button click

Processing time

1 - 10 minutes

Viewer systems

EMPAIA, FullFocus (Paige), Pathflow (Gestalt), PathPresenter, Proscia, Sectra, Digital Lab (Smart in Media), Telemis, Tribun

Regulatory Information

IVDR Certification

Pathway:

In Vitro Diagnostic Directive (IVDD)

Class:

General IVD Devices

Verified by Health AI Register

Scanner Brands Certified for Use (IVDR)

Roche, Phillips, 3DHistech, Hamamatsu, Leica

Scanner Models Certified for Use (IVDR)

Roche VENTANA DP 200, Philips IntelliSite Ultra Fast Scanner, 3DHistech PANNORAMIC 1000, Hamamatsu NanoZoomer S360, Leica Aperio GT 450

Other certifications

Not specified

Market Presence

On market since

May 2022

AI Platforms

Gestalt, Paige, PathPresenter, Proscia, Roche Navify, Sectra Amplifier Store, Smart in Media, Telemis, Tribun Health

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

One-time license fee, Pay-per-use, Subscription

Based on

Number of analyses

Evidence & Research

No research papers or evidence available for this product.

First published: Jul 30, 2025 | Last updated: Aug 1, 2025