- No public price.
- Not disclosed
- Not disclosed
- —
- 2018
- FR
Pathology
CB
Cleo Breast and Cleo Skin
by Primaa · founded 2018 · FR
AI detection of breast and skin cancer on pathology slides, for pathologists and pathology labs.
On this page
13/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market9/18
Founded 2018 (8 years)
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
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- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market6/6
Founded 2018 (8 years)
- Pricing transparency3/5
Pricing on request, no public amounts
AI detection of breast and skin cancer on pathology slides, for pathologists and pathology labs.
No public price.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Cleo Breast and Cleo Skin record, https://medaiverdict.com/tools/primaa, version November 2, 2026
Bottom line
Primaa's footer says that unless otherwise stated all products are research use only and not for use in diagnostic procedures, while its product pages claim CE marking under IVDR. The company, founded in 2018 with a Paris contact address, sells Cleo Breast for breast pathology and Cleo Skin for dermatopathology, and calls itself "an AI-based platform for automated and accurate cancer diagnosis." Its news page announces viewer integrations with Sectra, PathAI AISight Dx, Proscia, PathPresenter and Gestalt. The Cleo Breast solution page gives no CE status for carcinoma or mitosis detection, and openFDA holds no record for Primaa, so a lab built around those features or a US lab has less to go on.
Which Primaa features carry a CE mark?
Cleo Skin received CE marking under Regulation (EU) 2017/746 on March 12, 2026, which Primaa calls a world first for dermatopathology AI under IVDR. Cleo Breast macrometastasis detection was announced on September 9, 2025, and a later release dates that marking to May 25, 2025. Micrometastasis received a separate IVDR extension on September 10, 2026.
The Cleo Breast solution page says micrometastasis is "not CE marked," so page and news disagree on timing. The notified body behind these marks is not named. Cleo Breast is described as "intended to be used as an aid to diagnosis," with results reviewed by accredited doctors.
What does Cleo Breast detect?
On breast slides it detects invasive and in situ carcinoma with a heatmap, detects and counts mitoses, finds calcifications, and checks lymph node slides for macrometastases and micrometastases. It also offers a prioritized case work list and tumor measurements. TIL scoring, nuclear atypia and IHC quantification for Ki67, ER/PR and HER2 are listed as planned. Cleo Skin is described as dermatopathology AI for skin cancer detection.
Where does it plug in?
The integration announcements are PathAI AISight Dx (September 4, 2025), Proscia (October 15, 2025), PathPresenter (November 6, 2025 and September 8, 2026) and Gestalt (March 19, 2025), alongside Sectra. Primaa calls itself "vendors agnostic & interoperable" on scanners and names no model. It says it "does not collect any personal data" and cites GDPR.
A partner strip shows AP-HP, Institut Curie, Unilabs, Medipath, Pfizer Healthcare Hub and others. Primaa does not say which of these are customers.
What do the papers show?
Three papers carry a Primaa affiliation, and none is a prospective outcome study. A 2025 Diagnostics study evaluated AI mitosis detection in routine practice integration (PMID 40361944). A 2023 PLOS Digital Health paper covered multicenter detection of invasive carcinoma on whole slide images (PMID 36854026). A 2023 Journal of Medical Imaging paper trained a CycleGAN for stain adaptation in invasive carcinoma classification (PMID 38145285). No Cleo Skin paper is listed, and the vendor's November 2023 time-saving study has no PubMed record.
What does it cost?
Primaa's site carries no price list.
The verdict
A European lab running one of the named viewers can evaluate Cleo Breast for lymph node metastasis and Cleo Skin, the two features with the clearest CE-IVDR claims. A lab interested mainly in carcinoma or mitosis detection is buying features whose CE status the solution page leaves unstated.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
Who builds it
Cleo Breast and Cleo Skin (Primaa) was founded in 2018 in FR, putting it 8 years into market.
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