Indica Labs HALO AI vs Visiopharm
A university hospital in the EU that scores Ki-67 or HER2 on whole slide images starts with Visiopharm. The vendor says its ER, PR, HER2 and Ki-67 apps are certified under the IVDR, and a 2025 study measured its HER2 app against expert breast pathologists. Indica's CE-IVD AI is the prostate tool, so HALO AI trails for that hospital, and the HALO AI classifier add-on is a research product.
A US pathology department starting digital primary diagnosis goes to Indica. HALO AP Dx has two 510(k) clearances, K232833 from May 2024 and K252762 from November 2025, with the Leica Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD. They cover the case-management viewer. No Visiopharm product appears in the FDA database, which takes Visiopharm out of that US decision.
A pharma group that wants to train its own classifiers on brightfield and fluorescence slides can use either research platform, and both quote by enterprise contract with no public figure.
Pathology · Reviewed November 1, 2026
Indica Labs HALO AI
by Indica Labs
HALO image analysis and AI for pathology research, plus HALO AP Dx (FDA-cleared) and HALO Prostate AI (CE-IVD) for clinical use.
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
Indica Labs HALO AI
- HALO AP Dx 510(k) cleared, K232833 and K252762
- Cleared with Aperio GT 450 DX and NanoZoomer S360MD
- Train-by-example classifier for brightfield and fluorescence research
Visiopharm
- Vendor-stated IVDR apps for ER, PR, HER2 and Ki-67
- 2025 HER2-low agreement study with breast pathologists
- Quoted per module, no public price
Score
Each row shows points earned of points available under the published rubric.
Indica Labs HALO AI
33of 100
Visiopharm
43of 100
| Dimension | Indica Labs HALO AI | 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 | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Indica Labs HALO AI
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Visiopharm
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Indica Labs HALO AI
FDA decisions
K252762 (opens in new tab)510(k)2025-11-25
HALO AP Dx
K232833 (opens in new tab)510(k)2024-05-07
HALO AP Dx
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 | Indica Labs HALO AI | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | 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.