Indica Labs vs PathAI (2026)
Both sell a cleared platform for primary diagnosis with their own AI outside the US clearance, so the choice turns on scanners, hosting and ownership. Indica's HALO AP Dx is 510(k) cleared with the Hamamatsu NanoZoomer S360MD (K232833) and the Leica Aperio GT 450 DX (K252762); HALO AP, which runs Indica's Breast IHC, Lung PD-L1 and Prostate AI alongside third party AI, is CE-IVDR marked and research use only in the United States. PathAI's AISight Dx is cleared (K243391) with four named scanners, runs PathAI's research use only algorithms beside partners', and in May 2026 PathAI agreed to be acquired by Roche.
- You want HALO hosted on AWS inside an account you control.
- Two way integration with your laboratory information system matters.
- You also do research image analysis, which HALO and HALO AI cover.
- You want four scanners under the cleared label.
- You run MASH trials, where AIM-MASH AI Assist is qualified.
- Your laboratory network already uses AISight, as Labcorp and MedStar Health do.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Indica Labs and PathAI are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Indica Labs | PathAI |
|---|---|---|
| Primary category | Digital Pathology AI | Digital Pathology AI |
| Founded | 2007 | 2016 |
| Headquarters | Albuquerque, New Mexico, United States | Boston, Massachusetts, United States |
| Website | indicalab.com | pathai.com |
Side by Side
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Albuquerque based digital pathology company whose HALO AP Dx platform is FDA 510(k) cleared for primary diagnosis with named scanners (K232833 with the Hamamatsu NanoZoomer S360MD; K252762 adding the Leica Aperio GT 450 DX). HALO AP, which runs Indica's own AI (Breast IHC AI, Lung PD-L1 AI, Prostate AI) and hosted third party AI, is CE-IVDR marked in Europe, the UK and Switzerland and research use only in the United States.
Source: AI Health Index, September 2026
Digital pathology company selling the AISight image management system and its own AI algorithms. AISight Dx is FDA 510(k) cleared (K243391, June 2025) for primary diagnosis with four named scanners and CE-IVD marked in Europe, and is deployed at laboratories including Labcorp and MedStar Health.
Source: AI Health Index, September 2026
Questions buyers ask
How do Indica Labs and PathAI work with the EHR?
For Indica Labs, the HALO AP Dx page says the platform assembles cases from barcodes and LIS or LIMS data, keeps worklists updated from the LIS, generates the pathology report and sends it automatically to the LIS through an interface, and offers API-first connectivity; it is DICOM compliant and cleared for SVS and DICOM files from the Leica Aperio GT 450 DX.
The image management pages say AISight is interoperable with most major laboratory information systems and with Hamamatsu, Leica, Roche and Philips scanners, and that AISight Link, PathAI's open API, powers LIS integration and embeds partner algorithms in the viewer. The pages name no LIS product, no standard such as HL7 or DICOM, and no integration documentation. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
How do Indica Labs and PathAI handle patient data?
In Indica Labs' case, the product pages state that HALO AP provides built-in compliance with FDA 21 CFR Part 11 (electronic records and audit trails), HIPAA and GDPR. Under Cloud Services the deployment sits in an AWS account the customer controls, which keeps slide images in the customer's tenancy rather than a vendor environment.
The privacy notice (effective 13 February 2025), which covers PathAI's platforms, says PathAI requests only the minimum information needed and retains it only as long as necessary to provide the services or for compatible purposes, including providing additional services. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
Which settings and specialties do Indica Labs and PathAI cover?
With Indica Labs, the company serves clinical laboratories, research institutes, contract research organizations and companion diagnostic development, with named clinical users including the National Cancer Institute, Nottingham University Hospitals and the University of Bern.
In PathAI's case, the biomarker algorithms name their indications and supported antibody clones (PD-L1 in non-small cell lung, head and neck, melanoma and urothelial cancer; HER2, ER, PR and Ki-67 in breast), and the menu extends to ulcerative colitis and dermatopathology, but these are research use only in the United States with no validation named on the product pages. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
What evidence is published for Indica Labs and PathAI?
For Indica Labs, the 510(k) clearances for HALO AP Dx rest on validation of the viewing platform for primary diagnosis, and the company names deployments at the National Cancer Institute, the University of Washington (40 percent AWS cost savings in four months, a vendor figure), Nottingham University Hospitals, the University of Bern and Source BioScience.
Pulaski and colleagues (Nature Medicine 2025, 31:315 to 322, open access, PathAI led) validated AIM-MASH on 1,481 liver biopsies from four completed global MASH trials with about 13,000 independent reads, testing the algorithm alone and as an aid against a consensus ground truth set by panels of hepatopathologists. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Digital Pathology AI page.
Each clearance covers the platform, not the AI, and is tied to named scanners, so hardware and software are one decision. PathAI's Roche acquisition was pending at review. Neither publishes pricing. Rewritten 28 Sep 2026 after both records were reviewed.