Health AI Register Logo
ProductsPlatformsCompaniesNewsContact
ProductsMindpeak Breast Ki-67 RoI

Vendor source

Reviewed 21 Jul 2026

Completeness Strong (69%)

Mindpeak Breast Ki-67 RoI

Mindpeak GmbH

Mindpeak Breast Ki-67 RoI is software for automated analysis of digital histopathology images of invasive mamma carcinoma. It analyzes scanned, fixed, Ki-67 stained samples of invasive ductal and lobular carcinoma. The software detects and classifies IHC-stained tumor cells within predefined regions of interest (ROI) as not-stained (negative) or stained (positive). It provides a proliferation score based on the proportion of tumor-positive cells. Images must meet pre-analytical quality standards. Results are automated but require manual review, adjustment, and final diagnosis by a pathologist.

Supported by 3 papers

Mindpeak Breast Ki-67 RoI
Mindpeak Breast Ki-67 RoI
Mindpeak Breast Ki-67 RoI
Mindpeak Breast Ki-67 RoI
Mindpeak Breast Ki-67 RoI thumbnail 1
Mindpeak Breast Ki-67 RoI thumbnail 2
Mindpeak Breast Ki-67 RoI thumbnail 3
Mindpeak Breast Ki-67 RoI thumbnail 4

Key Features

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

General Information

Product name

Mindpeak Breast Ki-67 RoI

Modality

Histopathology

Main task

Scoring (IHC quantification)

Subspeciality

Breast pathology

Organ/Specimen source

Not specified

Disease targeted

Breast cancer

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

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

Mindpeak Breast Ki-67 RoI is not intended 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 female patients, male patients of any age, 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

Mindpeak Breast Ki-67 RoI - Mindpeak GmbH