- No public price. The pricing page returns a 404.
- Not disclosed
- Not disclosed
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- FI
Pathology
Aiforia
by Aiforia Technologies · FI
Pathology image analysis AI: CE-IVD prostate cancer biopsy suite and clinical suite viewer, plus research tools. No FDA clearance.
On this page
24/100Niche fit
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength18.6/28.8
3 peer-reviewed papers
- Vendor & Market6/18
Early-stage company
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers15/21
3 peer-reviewed papers
- RCT / meta-analysis / systematic review4/8
1 observational study (no RCT)
- Funding & adoption signal6/12
Early-stage company
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Pathology image analysis AI: CE-IVD prostate cancer biopsy suite and clinical suite viewer, plus research tools. No FDA clearance.
No public price. The pricing page returns a 404.
Bottom line
Aiforia is a Finnish pathology AI company with a CE-IVD marked Clinical Suite Viewer and a CE-IVD marked Prostate Cancer Biopsy AI for clinical labs in Europe, plus a platform for building custom image-analysis models. It has no FDA clearance. It fits a European pathology lab that wants CE-marked prostate decision support and has a compatible scanner and LIS. A US lab that needs FDA-authorized prostate AI has other vendors to choose from, and a buyer wary of a small listed company's finances has reason to read the funding history below first.
What is Aiforia and who sells it?
Aiforia Technologies Plc is headquartered in Helsinki, with offices in Paris and Cambridge, Massachusetts. It began as a spin-off from the Institute for Molecular Medicine Finland and the University of Helsinki, in 2013 according to Dealroom and 2014 according to Tracxn. It has traded on Nasdaq First North Growth Market Helsinki since December 2021 under the ticker AIFORIA. Jukka Tapaninen is CEO.
Funding includes a EUR 5.0M Series A in 2017, a EUR 25.2M Series B in 2021 with investors such as PHC, Aktia Nordic Micro Cap and Epredia, later equity raises, and a EUR 20M European Investment Bank debt facility reported for July 2026. PitchBook puts 2025 revenue at about USD 4.0M. That is a small revenue base and a record of repeated capital raises, which a multi-year purchase has to weigh.
What does Aiforia sell?
Clinical suites cover breast, lung, prostate, colon, gastric, QuantCRC and lymph node metastasis. Aiforia Create lets labs build their own models, and research and veterinary products are sold alongside. The company has announced a CE-IVD marked Clinical Suite Viewer and a next-generation Prostate Cancer Biopsy AI that is CE-IVD marked. The company describes its aim as transforming pathology image analysis with AI for clinical, preclinical and academic labs.
Aiforia reported IVDR certification in February 2025. A product register lists the cribriform Gleason 4 and perineural invasion models as IVDR Class C, and the prostate suite is described as research use only or for performance study use outside the EU and EEA.
What about FDA status and security?
Aiforia has no FDA clearance and makes no FDA claim. On prostate biopsy, two FDA-authorized tools exist, Paige Prostate Detect and Ibex Prostate Detect.
The security page lists ISO 27001, SOC 2 Type II, ISO 13485 and GDPR, plus "HIPAA policies and procedures." Scanners and LIS are not named, and the homepage says only that Aiforia integrates with any existing laboratory infrastructure. EHR integration is not stated.
What does the evidence say?
Three papers name Aiforia in the abstract: bone marrow cell classification (2025 Journal of Hematopathology), a model of lamina propria fibrosis in eosinophilic esophagitis (2026 Journal of Pathology Informatics) and Ki67 scoring in gastrointestinal neuroendocrine tumours (2025 Scientific Reports). These are lab studies built with the platform, and they show the model-building tool in use.
No Aiforia-specific prostate validation study is published. Independent user reviews are not available either, and the trade press coverage is financial.
How much does Aiforia cost?
Aiforia lists no price, so any figure has to come from a quote.
How does it stand against the FDA-authorized prostate tools?
According to FDA records, Paige Prostate Detect carries a De Novo authorization from September 2021, and Ibex Prostate Detect received 510(k) clearance in early 2025. Aiforia has neither. What it has on the other side is a model-building tool and clinical suites beyond prostate, by its own listing.
The verdict
Aiforia suits a European lab that wants CE-IVD marked tools and the option to build its own models. The prostate module needs the most scrutiny, because the notified body, class and scanner validation for it are not public and no prostate study backs it. A US lab should buy from Paige or Ibex, and a lab that cannot accept a multi-year contract with a vendor earning about USD 4.0M a year should look at a larger company.
Editorial review last generated October 15, 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 | — | — | No public price. The pricing page returns a 404. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries CE-IVDR per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
3 peer-reviewed studies indexed on PubMed evaluate Aiforia in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- A deep-learning algorithm (AIFORIA) for classification of hematopoietic cells in bone marrow aspirate smears based on nine cell classes-a feasible approach for routine screening?
- Saft L, Vaara E, Ljung E, et al.· J Hematop· 2025
- Bone marrow cytology plays a key role for the diagnosis and classification of hematological disease and is often the first step in the acute setting of unclear cytopenia. AI applications represent a powerful tool in digital image analysis and can improve the diagnostic workflow and accuracy. The aim of this study was to develop an algorithm for the automated detection and classification of hematopoietic cells in digitized bone marrow aspirate smears for potential implementation in the clinical laboratory. The AIFORIA create platform (Aiforia Technologies, Plc, Helsinki, Finland) was used to d…
- Comparing non-machine learning vs. machine learning methods for Ki67 scoring in gastrointestinal neuroendocrine tumors.
- Mola N, Weishaupt H, Krasontovitsch V, et al.· Sci Rep· 2025
- The Ki67 score is a crucial prognostic biomarker for neuroendocrine tumors, but its manual assessment is labor-intensive, requiring the counting of 500-2,000 cells in hotspots. Digital image analysis could streamline this process, yet few comprehensive comparisons exist between different tools. We compared a non-machine learning (non-ML) tool (ImageScope, Leica Biosystems) with a machine learning (ML) tool (Aiforia Create, Aiforia Technologies) on Ki67-stained slides from 10 low proliferative neuroendocrine tumor cases (Ki67 score < 5%, eight regions per slide). Performance metr…
- A machine learning model of lamina propria fibrosis in eosinophilic esophagitis for prediction of fibrostenotic disease.
- Sivasubramaniam P, Shabaan A, Elhalaby R, et al.· J Pathol Inform· 2026
- Eosinophilic esophagitis (EoE) is a chronic immune-mediated disease that can progress to fibrostenotic complications. Lamina propria fibrosis (LPF) plays a critical role in this progression but is difficult to assess reliably in routine biopsies. We aimed to develop and validate an artificial intelligence (AI) model to quantify LPF on hematoxylin and eosin (H&E)-stained slides and to evaluate its ability to predict fibrostenotic disease. We used a cloud-based platform (Aiforia Inc., Cambridge, MA, USA) to train a supervised AI model to recognize several histological features of EoE, including…
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