PathAI AISight vs Visiopharm
PathAI's AI is labeled research use, and its two FDA clearances, K212361 from 2022 and K243391 from June 2025, cover the AISight viewer and image management system. A US laboratory director moving to digital primary diagnosis on a Hamamatsu or Leica scanner picks PathAI, since no Visiopharm product appears in the FDA database.
Visiopharm carries the diagnostic algorithms. The vendor counts at least nine certified under IVDR for EU and UK customers, and its HER2 app was the subject of a 2025 agreement study against expert breast pathologists. A breast unit in Denmark standardizing HER2-low reporting should skip PathAI, whose algorithms cannot be used diagnostically.
Roche agreed to acquire the company on May 7, 2026 and expects to close in the second half of 2026, so a multi-year buyer signs with a vendor that is mid-sale. Visiopharm was bought by Grundium Oy in a deal announced on May 21, 2026, with the effect on roadmap and pricing unknown.
Pathology · Reviewed November 1, 2026
PathAI AISight
by PathAI · founded 2016
Cloud image management for digital pathology with AISight Dx, cleared for primary diagnosis, plus biopharma AI services.
Visiopharm
by Visiopharm
Pathology image-analysis software with CE-IVD apps for breast, lung and prostate biomarkers and a research-use platform.
When to pick each one
PathAI AISight
- AISight Dx cleared by FDA for primary diagnosis
- Cleared viewer works with two named scanners
- Quote only, no public price
Visiopharm
- Vendor-stated IVDR apps for EU and UK labs
- HER2 app compared with expert breast pathologists
- ISO 13485:2016 certificate, valid to December 2027
Score
Each row shows points earned of points available under the published rubric.
PathAI AISight
40of 100
Visiopharm
43of 100
| Dimension | PathAI AISight | Visiopharm | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 0 / 18 | +18 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| 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 | 0 / 21 | 21 / 21 | -21 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 8.4 / 12 | 6 / 12 | +2.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 0 / 6 | +6 |
Scroll horizontally to see every column.
Pricing
PathAI AISight
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Billing period, trial and refund not stated. |
Visiopharm
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
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
Visiopharm
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
5 PubMed records name Visiopharm.
- Inter-rater agreement of HER2-low scores between expert breast pathologists and the Visiopharm digital image analysis application (HER2 APP, CE2797). (opens in new tab)
- Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: the CONFIDENT-B single-center, non-randomized clinical trial. (opens in new tab)
- Head-to-Head Comparison of 2 Artificial Intelligence Tools for Detecting Lymph Node Metastases in Whole-Slide Pathology Images Within and Beyond Their Intended Use. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | PathAI AISight | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2016 | n/a |
| HQ | US | DK |
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.