Vendor source
Reviewed 21 Jul 2026
Completeness Strong (72%)
CLEO BREAST is a software for use with digitized H&E stained breast biopsy & excision tissues. CLEO BREAST employs AI-based algorithms to assist pathologists in their diagnostic journey, integrating AI-enhanced tools to detect the presence of critical biomarkers, such as Invasive Carcinoma, Metastases, Mitoses, Calcifications and Emboli. By incorporating these models, CLEO BREAST not only streamlines the diagnostic process but also heightens its precision. This approach aids pathologists in elevating diagnostic accuracy, curtailing turnaround times, and optimizing lab efficiency. The pathologist has to review the results of CLEO BREAST and is responsible for the final diagnosis.
Supported by 3 papers





General Information
Product name
Company
Modality
Main task
Subspeciality
Organ/Specimen source
Not specified
Disease targeted
Specimen type
Staining
Stain subtype
Not specified
Regulatory Information
Pathway:
In Vitro Diagnostic Regulation (IVDR)
Class:
Class C
Verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Not specified
Scanner Models Certified for Use (CE-IVD)
Not specified
Other certifications
Not specified
Evidence & Research
Peer-Reviewed Papers
Evaluating AI-Based Mitosis Detection for Breast Carcinoma in Digital Pathology: A Clinical Study on Routine Practice Integration
Diagnostics · Apr 2025
Standardized CycleGAN training for unsupervised stain adaptation in invasive carcinoma classification for breast histopathology
Journal of Medical Imaging · Dec 2023
Multicenter automatic detection of invasive carcinoma on breast whole slide images
PLOS Digital Health · Feb 2023
Technical Specifications
Patient population age
Input
Input format
Output
Output format
Not specified
Integration
Deployment
Trigger for analysis
Processing time
Population
Viewer systems
Market Presence
On market since
AI Platforms
Resellers
Not specified
Countries present
Not specified
Paying clinical customers
Research/test users
Not specified
Pricing Information
Pricing model
Based on
Source: Vendor | First published: Jul 30, 2025 | Last updated: Jul 21, 2026