Indica Labs HALO AI vs PathAI AISight
A lab running Hamamatsu S360MD or Leica GT 450 DX scanners that wants cloud image management can take PathAI's AISight Dx, cleared for primary diagnosis on FFPE slides and CE-IVD for the EEA, UK and Switzerland. Indica's HALO AP Dx clearances name the same two scanners, so scanner choice does not separate them. HALO AI separates them on the research side, since it trains segmentation and phenotyping classifiers by example for groups that build their own readouts, and Indica claims deployments at all top 20 pharma companies. PathAI's clearances cover the viewer while its algorithms are research use, and it sold its clinical lab to Quest in June 2024. Roche signed a merger agreement for PathAI in May 2026, $750M upfront plus up to $300M in milestones, with closing expected in the second half of 2026. A health system signing now would face a change of owner that Indica, independent with a Leica Biosystems investment, does not bring.
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.

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
Indica Labs HALO AI
- HALO AP Dx holds FDA clearance K232833
- Train-by-example classifiers for research slides
- Leica Biosystems resells its image management products
PathAI AISight
- AISight Dx cleared for primary diagnosis, K243391
- Cloud-native image management system
- CE-IVD for EEA, UK and Switzerland
Score
Each row shows points earned of points available under the published rubric.
Indica Labs HALO AI
33of 100
PathAI AISight
40of 100
| Dimension | Indica Labs HALO AI | PathAI AISight | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| 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 | 0 / 21 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Indica Labs HALO AI
| 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
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
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 | Indica Labs HALO AI | PathAI AISight |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2016 |
| HQ | n/a | 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.
