Vendor source
Reviewed 21 Jul 2026
Completeness Strong (78%)
Stratipath Breast
StratipathStratipath Breast is an AI-based image analysis software intended for risk stratification of adult female breast cancer patients based on digital histological images. Stratipath Breast provides prognostic information through low-risk to high-risk classification levels that are associated with the patient’s risk of recurrence. The results are intended to help oncologists and pathologists assess the risk of relapse in early breast cancer patients.
Supported by 3 papers
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
Peer-Reviewed Papers
Validation of a deep learning-based AI model for breast cancer risk stratification in postmenopausal ER+/HER2-breast cancer patients
The Breast · Dec 2025
Validation of an AI-based solution for breast cancer risk stratification using routine digital histopathology images
Breast Cancer Research · Aug 2024
Clinical evaluation of deep learning-based risk profiling in breast cancer histopathology and comparison to an established multigene assay
Breast Cancer Research and Treatment · Apr 2024
Technical Papers
Technical Specifications
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Source: Vendor | First published: Jul 30, 2025 | Last updated: Jul 21, 2026