Vendor source

Reviewed 21 Jul 2026

Completeness Strong (67%)

Mindpeak Breast Ki-67 HS

Mindpeak GmbH

Software for automated analysis of digital histopathology images of invasive mamma carcinoma tissue samples. It supports the analysis of digital images from scanned, Ki-67 stained samples of invasive ductal and lobular carcinoma. The software detects and classifies IHC-stained tumor cells in whole slide image, identifies one or several tumor regions according to the hotspot method, and provides a proliferation score. Tumor cells are classified as not-stained (tumor negative) or stained (tumor positive). Pathologist has to review the results and is responsible for the final diagnosis.

No papers to support — we monitor for new evidence.

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Key Features

  • Cancer detection
  • Cell classification
  • Proliferation Score
  • Tissue segmentation

General Information

Product name

Mindpeak Breast Ki-67 HS

Modality

Histopathology

Main task

Scoring (IHC quantification)

Subspeciality

Breast pathology

Organ/Specimen source

Not specified

Disease targeted

Breast cancer (invasive mamma carcinoma)

Specimen type

Not specified

Staining

IHC

Stain subtype

KI-67

Regulatory Information

CE-IVD Certification

Pathway:

In Vitro Diagnostic Directive (IVDD)

Class:

General IVD Devices

Verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Roche, Phillips, 3DHistech, Hamamatsu, 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

whole slide image, primary breast cancer tissue, 0.5µm/pixel ± 0.05 µm/pixel resolution, 20x scan magnification

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, Locally on dedicated hardware, Locally virtualized (virtual machine, docker)

Trigger for analysis

Automatically, right after the image acquisition

Processing time

1 - 10 minutes

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, samples from non-adult patients, metastatic lesions, post-therapy samples.

Viewer systems

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

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

Source: Vendor | First published: Jul 30, 2025 | Last updated: Jul 21, 2026