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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 logo

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 logo

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
Read the full Indica Labs HALO AI review

PathAI AISight

  • AISight Dx cleared for primary diagnosis, K243391
  • Cloud-native image management system
  • CE-IVD for EEA, UK and Switzerland
Read the full PathAI AISight review

Score

Each row shows points earned of points available under the published rubric.

Indica Labs HALO AI

33of 100

Competitive

PathAI AISight

40of 100

Competitive
Score by dimension for Indica Labs HALO AI and PathAI AISight
DimensionIndica Labs HALO AIPathAI AISightDifference
FDA clearance18 / 1818 / 180
HIPAA / SOC2 / BAA0 / 100 / 100
EHR integrations (count)0 / 4.20 / 4.20
Top-3 EHR coverage (Epic / Oracle / Athena)0 / 2.40 / 2.40
Peer-reviewed papers0 / 210 / 210
RCT / meta-analysis / systematic review0 / 7.80 / 7.80
Funding & adoption signal8.4 / 128.4 / 120
Pricing transparency2.5 / 52.5 / 50
Years in market0 / 66 / 6-6

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How scores are computed

Pricing

Indica Labs HALO AI

TierMonthlyAnnualNotes
Enterprisen/an/aNo public price.

PathAI AISight

TierMonthlyAnnualNotes
Enterprisen/an/aNo public price. Billing period, trial and refund not stated.

Evidence

Indica Labs HALO AI

FDA decisions

PathAI AISight

FDA decisions

Compliance and integrations

Documented from each vendor’s own pages.

SpecIndica Labs HALO AIPathAI AISight
Free tierNo / unverifiedNo / unverified
HIPAANo / unverifiedNo / unverified
SOC 2 Type IINo / unverifiedNo / unverified
EHR integrationsNot specifiedNot specified
Foundedn/a2016
HQn/aUS

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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.