Artera vs PathAI AISight
A lab picking a cloud viewer for primary diagnosis on the Hamamatsu NanoZoomer S360MD or the Leica Aperio GT 450 DX buys PathAI. AISight Dx was cleared as K243391 in June 2025, a predetermined change control plan lets PathAI add scanners, displays and formats without a new 510(k), and the platform is CE-IVD for the EEA, UK and Switzerland. PathAI's clearances cover the viewer and image management. Roche signed a merger agreement in May 2026 at $750M upfront plus up to $300M in milestones, with closing expected in the second half of 2026.
Artera sells prostate and breast prognosis tests to clinicians. A clinician ordering a prognosis after a prostate biopsy uses Artera, and the homepage lists SOC 2 Type II and HIPAA compliance. The vendor says the test is fully reimbursed for Medicare patients, with many commercial plans covering it. A lab director choosing a viewer and a clinician choosing a prognosis test face separate purchase decisions.
Pathology · Reviewed November 2, 2026
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.
PathAI AISight
by PathAI · founded 2016
Cloud image management for digital pathology with AISight Dx, cleared for primary diagnosis, plus biopharma AI services.
When to pick each one
Artera
- Vendor claims full Medicare reimbursement
- SOC 2 Type II and HIPAA listed on homepage
PathAI AISight
- AISight Dx cleared for primary diagnosis, K243391
- Cleared with Hamamatsu and Leica Aperio scanners
- PCCP adds scanners without a new 510(k)
Score
Each row shows points earned of points available under the published rubric.
Artera
65of 100
PathAI AISight
40of 100
| Dimension | Artera | PathAI AISight | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 10 / 10 | 0 / 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 | 0 / 21 | +14.7 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Artera
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
PathAI AISight
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Billing period, trial and refund not stated. |
Evidence
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)
PathAI AISight
FDA decisions
K243391 (opens in new tab)510(k)2025-06-26
AISight Dx
K212361 (opens in new tab)510(k)2022-08-11
Novo
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Artera | PathAI AISight |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2016 |
| HQ | US | 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.