- No public price.
- Not disclosed
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Pathology
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.
On this page
25/100Niche fit
- Regulatory & Compliance18/28
FDA cleared (2 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market8.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (2 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
HALO image analysis and AI for pathology research, plus HALO AP Dx (FDA-cleared) and HALO Prostate AI (CE-IVD) for clinical use.
No public price.
Bottom line
HALO AI is a research add-on from Indica Labs, a train-by-example deep-learning classifier that runs inside the HALO image analysis software and HALO Link. Indica's clinical product is HALO AP Dx, a case-management and primary-diagnosis platform with two FDA 510(k) clearances, and a separate prostate tool, HALO Prostate AI, is CE-IVD marked. HALO AI fits a research or pharma pathology group that wants to tune its own classifiers on brightfield and fluorescence slides. A lab that needs a diagnostic tool should evaluate HALO AP Dx instead.
Who is Indica Labs and what is HALO AI?
Indica Labs is based in Albuquerque, New Mexico. The vendor claims HALO is deployed at all of the top 20 pharmaceutical companies.
Leica Biosystems is the exclusive reseller of Indica's image management products and made a strategic investment in January 2025, according to IPT Online. Leica's Aperio HALO AP and Aperio AI Store were developed with Indica.
The vendor describes HALO AI as "a collection of segmentation, classification, and phenotyping tools for brightfield and fluorescence applications," tuned to a specific application through the train-by-example interface. HALO 4.0 added an AI annotation tool, real-time training tuning and probability maps.
How do the three products differ?
HALO AI is the classifier described above, and no 510(k) lists it as a device.
HALO AP Dx is "FDA-cleared case-centric pathology platform that enables primary diagnosis, remote working," in the vendor's words. Two 510(k) records name Indica as applicant: K232833 on 7 May 2024 under product code PSY, and K252762 on 25 November 2025 under product code QKQ, announced on 3 December 2025. They cover the case-management viewer. The cleared configurations pair it with the Leica Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD, using SVS and DICOM files.
HALO Prostate AI is described as a "CE-IVD marked AI tool that detects and grades prostate adenocarcinoma in core needle biopsy specimens."
What does the evidence say?
Testimonials on the vendor's site come from the Medical University of Graz, the University of Washington and the NCI, among others. The vendor reports that clinical revenue grew 260% in a December 2025 release. That is a business figure and carries no diagnostic performance data.
How do you buy it?
Quotes come from Indica, and for the image management products from Leica Biosystems as the exclusive reseller. No price is listed.
The verdict
For a research group, HALO AI is a plausible classifier-training tool, and the vendor reports a large pharma installed base. A diagnostic lab should look at HALO AP Dx with one of the two cleared scanners. A buyer who needs published performance data for HALO AI itself should hold off, since the vendor's support is testimonials and revenue growth.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
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