Vendor source
Reviewed 21 Jul 2026
Completeness Strong (67%)
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.



General Information
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Regulatory Information
Pathway:
In Vitro Diagnostic Directive (IVDD)
Class:
General IVD Devices
Verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Scanner Models Certified for Use (CE-IVD)
Not specified
Other certifications
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Evidence & Research
No research papers or evidence on file yet.
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Technical Specifications
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Viewer systems
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Source: Vendor | First published: Jul 30, 2025 | Last updated: Jul 21, 2026