Aiforia vs Artera
The regulatory routes differ. ArteraAI Prostate software holds an FDA De Novo (DEN240068, decided July 31, 2025), and the commercial test runs in Artera's CLIA lab as a lab-developed test on the same platform. Aiforia's prostate biopsy suite is CE-IVD marked, and the vendor labels it RUO/PSO outside the EU and EEA.
A urology clinic that wants a prognosis for a man 55 or older with prostate cancer picks Artera, which works from existing H&E slides. A pathology lab in the EU that wants image analysis software in house fits Aiforia, and a lab can build its own models in Aiforia Create. A clinic ordering a test and a lab buying software are separate purchases. Aiforia's pricing page returns a 404, and Artera's homepage states no price.
Aiforia's security page lists ISO 27001, SOC 2 Type II and ISO 13485, and Artera's homepage lists SOC 2 Type II and HIPAA.
Pathology · Reviewed November 2, 2026
Aiforia
by Aiforia Technologies
Pathology image analysis AI: CE-IVD prostate cancer biopsy suite and clinical suite viewer, plus research tools. No FDA clearance.
Artera
by Artera
AI risk scores from H&E slides for prostate and breast cancer, run by a CLIA lab. ArteraAI Prostate software is FDA De Novo authorized.
When to pick each one
Aiforia
- CE-IVD marked prostate biopsy suite
- Aiforia Create builds a lab's own models
- ISO 27001, SOC 2 Type II and ISO 13485
Artera
- ArteraAI Prostate holds FDA De Novo DEN240068
- Risk scores from existing H&E slides
- Prostate and breast tests run in a CLIA lab
Score
Each row shows points earned of points available under the published rubric.
Aiforia
31of 100
Artera
65of 100
| Dimension | Aiforia | Artera | Difference |
|---|---|---|---|
| FDA clearance | 0 / 18 | 18 / 18 | -18 |
| HIPAA / SOC2 / BAA | 0 / 10 | 10 / 10 | -10 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 14.7 / 21 | 14.7 / 21 | 0 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 7.8 / 7.8 | -3.9 |
| Funding & adoption signal | 6 / 12 | 3 / 12 | +3 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Aiforia
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The pricing page returns a 404. |
Artera
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Aiforia
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
3 PubMed records name Aiforia.
- 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? (opens in new tab)
- Comparing non-machine learning vs. machine learning methods for Ki67 scoring in gastrointestinal neuroendocrine tumors. (opens in new tab)
- A machine learning model of lamina propria fibrosis in eosinophilic esophagitis for prediction of fibrostenotic disease. (opens in new tab)
Artera
FDA decisions
K254115 (opens in new tab)510(k)2026-05-04
ArteraAI Breast
DEN240068 (opens in new tab)De Novo2025-07-31
ArteraAI Prostate
Peer-reviewed
4 PubMed records name Artera.
- Multi-institutional Patient-level Comparison of Decipher Genomic Classifier and Artera Multimodal Artificial Intelligence (MMAI) in Prostate Cancer. (opens in new tab)
- External validation of a digital pathology-based multimodal artificial intelligence-derived prognostic model in patients with advanced prostate cancer starting long-term androgen deprivation therapy: a post-hoc ancillary biomarker study of four phase 3 randomised controlled trials of the STAMPEDE platform protocol. (opens in new tab)
- A multicentre implementation trial of an Artificial Intelligence-driven biomarker to inform Shared decisions for androgen deprivation therapy in men undergoing prostate radiotherapy: the ASTuTE protocol. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Aiforia | Artera |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | FI | US |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
Digital pathology workflows with FDA-cleared cancer detection (prostate, breast, colon), IHC scoring (HER2, Ki67), and AI-powered image management. Tempus, PathAI, Proscia dominate.