Aiforia vs Primaa (2026)
Both sell CE-IVD pathology AI with no FDA clearance, differing in breadth and in where the software runs. Aiforia's Clinical Suites cover breast, lung, prostate, gastric and colon cancer on Aiforia's cloud platform, and Aiforia Create lets laboratories build models. Primaa's Cleo Breast is a CE-IVDR marked aid to primary diagnosis for breast tissue, Cleo Skin was CE marked under the IVDR in March 2026, and Cleo runs inside the customer's own network or inside host platforms including PathAI's AISight, PathPresenter, Proscia and Gestalt.
- You want five cancer types and your own model building on one platform.
- A hosted service suits you, with ISO 27001, SOC 2 Type II and ISO 13485 named.
- Lung, prostate, gastric or colon work is in scope.
- Breast and skin are your priorities.
- You want the software inside your own network or inside a viewer you already run, such as AISight, PathPresenter, Proscia or Gestalt.
- You want a vendor that states it collects no personal data.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Aiforia and Primaa are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Aiforia | Primaa |
|---|---|---|
| Primary category | Digital Pathology AI | Digital Pathology AI |
| Founded | 2013 | 2018 |
| Headquarters | Helsinki, Finland | Paris, France |
| Website | aiforia.com | primaalab.com |
Side by Side
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Finnish deep learning pathology company, listed in Helsinki, selling cloud based image analysis for clinical diagnostics and preclinical research. Its Aiforia Clinical Suites cover breast, lung, prostate, gastric and colon cancer on a platform with a worklist, viewer and case reporting; each clinical model is CE-IVD marked for diagnostic use in the EU and EEA under the IVDR, or research use only, and all are research use only in the United States.
Source: AI Health Index, September 2026
Paris based pathology AI company whose Cleo tools detect and quantify cancer features in whole slide images. Cleo Breast is a CE-IVDR marked aid to primary diagnosis for breast tissue, covering invasive carcinoma, mitoses, calcifications and lymph node metastases (micrometastasis detection CE-IVDR marked in September 2026), and Cleo Skin, CE marked under the IVDR in March 2026, classifies melanoma, nevus and squamous and basal cell carcinoma and measures tumors and margins.
Source: AI Health Index, September 2026
Questions buyers ask
How do Aiforia and Primaa work with the EHR?
The clinical solutions page says Aiforia integrates into existing laboratory systems, with publicly available API specifications, and that customers choose among deployment options. A sales and marketing partnership with Siemens Healthineers extends distribution.
With Primaa, the product pages say Cleo integrates fully into the laboratory workflow and with laboratory machines. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
How do Aiforia and Primaa handle patient data?
In Aiforia's case, the company names ISO 27001 and SOC 2 Type II, states that its HIPAA Security Rule controls were independently tested, and says customers can choose between deployment options.
For Primaa, the Cleo Breast and Cleo Skin pages state that Cleo does not collect any personal data, that the company's activities follow the GDPR, and that all data stay within the customer's own network. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
What evidence is published for Aiforia and Primaa?
Academic work using the Aiforia Create platform appears in Nature and in Mayo Clinic and MSKCC studies, though most of that is research use rather than validation of the clinical suites.
In Primaa's case, the company's evidence library lists a multicenter study of automatic invasive carcinoma detection on breast whole slide images (PLOS Digital Health), a 2025 evaluation of AI based mitosis detection with Cleo Breast, and a 2023 study of time savings with Cleo Breast, and the Cleo Breast page reports a clinical study with participating pathologists. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
How much do Aiforia and Primaa leave to the clinician?
For Aiforia, the marketed benefit is time saved and consistency, not autonomous sign out, and the CE-IVD models are sold as diagnostic aids.
With Primaa, the Cleo Breast page says the tool is intended as an aid to diagnosis whose results must be reviewed by accredited doctors, and Cleo Skin carries the same sentence. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Digital Pathology AI page.
Neither is FDA cleared; both are research use only in the United States. Neither publishes pricing. Rewritten 28 Sep 2026 after both records were reviewed.