Vendor source

Reviewed 21 Jul 2026

Completeness Strong (72%)

Cleo Breast

Primaa

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

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Key Features

  • Calcification detection
  • DCIS detection
  • IC detection
  • lymph node metastasis detection
  • Mitosis count

General Information

Product name

Cleo Breast

Company

Modality

Histopathology

Main task

Detection, Quantification, Triage

Subspeciality

Breast pathology

Organ/Specimen source

Not specified

Disease targeted

Breast cancer

Specimen type

Biopsy, Excision

Staining

H&E

Stain subtype

Not specified

Regulatory Information

CE-IVD Certification

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

Technical Specifications

Patient population age

Adult

Input

H&E, whole slide image, 0.5 mpp

Input format

3DHistech (MRXS), DICOM, NDPI, Philips (iSyntax, i2Syntax), SVS, TIFF, Ventana (BIF)

Output

Heatmap, image annotations, draft histopathological report, and probability of pathology presence.

Output format

Not specified

Integration

Integration via AI marketplace or distribution platform, Integration with IMS (Image Management System), Stand-alone third party application

Deployment

Cloud-based, Hybrid, Locally virtualized (virtual machine, docker)

Trigger for analysis

Right after the image acquisition, Triggered by a user through e.g. a button click

Processing time

1 - 10 minutes

Population

The target patient group of CLEO BREAST is all adult female patients (above 18 years old) with a suspicion of invasive & in situ carcinoma on imaging requiring histological exploration

Viewer systems

Proscia ConcentriqDX, Sectra, Telemis, Tribun

Market Presence

On market since

November 2021

AI Platforms

HCKonnect, Sectra Amplifier Store

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

10+

Research/test users

Not specified

Pricing Information

Pricing model

Subscription

Based on

Number of analyses

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