PathAI

Digital pathology image management with an FDA cleared platform for primary diagnosis

As of 1 September 2026, PathAI's pricing is not published; the vendor quotes on request. PathAI sells AISight for digital pathology, and the distinction that matters is that AISight is research use only while AISight Dx is FDA cleared for primary diagnosis and CE-IVD marked. Softwr lists it under Healthcare. PathAI is made by PathAI, Inc., available on Web.

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Overview

What PathAI does

PathAI is a Boston company building software for digital pathology. Its image management system, AISight, ingests whole slide images, manages the slide archive and provides the viewing and case assembly environment pathologists work in. Alongside that it develops AI algorithms for research and biopharmaceutical work, including quantitative scoring used in clinical trials and drug development, which is where a large part of its revenue historically came from. The fact that decides a purchase is a two letter suffix. AISight is labelled for research use only and not for clinical use in diagnostic procedures. AISight Dx received FDA 510(k) clearance for use in primary diagnosis in June 2025 and is CE-IVD marked for primary diagnosis in the European Economic Area, the United Kingdom and Switzerland. A laboratory that buys AISight expecting to retire its microscopes and sign out cases digitally has bought a research tool. This distinction is not hypothetical marketing detail; it determines whether a pathologist can legally render a primary diagnosis on a screen. Buyers are academic medical centres, large reference laboratories and pharmaceutical companies, and PathAI has deployment relationships with Labcorp, Moffitt Cancer Center, Northwestern Medicine and MedStar Health. The trade off is that going fully digital is a capital and operations project rather than a software purchase: scanners, storage, network capacity between the histology laboratory and the reading location, and a validation study per subspecialty. The software licence is frequently the smallest number in the business case.

What people use it for

An academic medical centre going digital for primary diagnosis that needs the FDA cleared AISight Dx configuration rather than the research labelled version
A reference laboratory consolidating subspecialty sign out across sites so a specialist pathologist can read cases from any location
A pharmaceutical company needing consistent quantitative scoring of trial biopsies across many sites and readers
A laboratory with a mixed scanner estate that needs one image management layer rather than each scanner vendor viewer

Where it falls short

Concrete and checkable, so you can decide whether any of them matter to you. This is the half of a review a vendor will not write about PathAI.

AISight is labelled research use only and cannot be used for primary diagnosis; only AISight Dx carries the FDA clearance and CE-IVD mark, and laboratories regularly buy the wrong configuration and discover they cannot sign out on it.
The software licence is usually the smallest line in a digital pathology project, behind scanners, storage and network capacity, so a business case built around the software cost understates the real investment by a wide margin.
Whole slide images are very large, so a laboratory that does not model storage growth and retention policy from the start faces storage costs that grow faster than case volume and dominate the renewal.
Clinical validation is required per subspecialty rather than once for the platform, which means dermatopathology, gastrointestinal and breast each need their own concordance study and pathologist time before go live.
PathAI competes against pathology incumbents that also sell the scanners, and a laboratory buying an independent image management layer takes on the integration risk between scanner vendor and software vendor itself.

Cross-shopped

What people choose instead of PathAI

Each pairing was judged by two reviewers asking whether a buyer would genuinely weigh the two against each other. The ones that failed were deleted rather than published.

PathAIvs
Techcyte
Techcyte: Techcyte covers clinical, veterinary and environmental laboratory disciplines that PathAI does not, though much of its US portfolio is research use only
PathAIvs
Ambra Health
Ambra Health: If the goal is only to store and share images across sites rather than to sign out digitally, a cloud VNA is far cheaper

Pricing

What PathAI costs

Taken from the vendor's own pricing page. Prices move, so check before you buy.

AISight

On request

Priced by annual slide or case volume and by pathologist seats
AISight Dx, the clinically cleared configuration, quoted separately from research use AISight
Image storage priced by capacity and retention policy
Validation support, LIS interfaces and deployment quoted as professional services
No published rate card

Capabilities

Features

AISight image management
Whole slide image ingestion, archive, case assembly and viewing, labelled research use only
AISight Dx
The FDA 510(k) cleared and CE-IVD marked configuration permitted for primary diagnosis
Scanner interoperability
Ingests images from multiple whole slide scanner vendors rather than tying the laboratory to one
Case and worklist management
Assembles slides into cases, routes to subspecialty pathologists and tracks sign out status
AI algorithm deployment
Runs PathAI and partner algorithms over slides, with outputs distinguished by research and clinical labelling
Biopharmaceutical research tooling
Quantitative scoring and annotation workflows used in drug development and clinical trials
LIS integration
Interfaces to anatomic pathology laboratory information systems for accession and result flow

Answered, with sources

Questions people ask

Each answer names the page it came from, so you can check it rather than take our word for it.

What is the difference between AISight and AISight Dx?

AISight is for research use only and not for clinical diagnostic use. AISight Dx received FDA 510(k) clearance in June 2025 for primary diagnosis and is CE-IVD marked in the EEA, UK and Switzerland. Only the Dx configuration can be used to sign out cases.

Can we use our existing scanners?

Yes. AISight is designed to ingest images from multiple whole slide scanner vendors, which is one of the main reasons laboratories choose an independent image management layer.

Do the AI algorithms carry the same clearance as the platform?

No. The platform clearance covers image management for primary diagnosis. Individual algorithms have their own labelling, and many are research use only. Check each one separately.

Is pricing published?

No. It is quoted by slide or case volume, pathologist seats and storage, with the clinically cleared configuration priced separately.

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Softwr does not host reviews and shows no star rating for PathAI, because a rating we did not collect is not ours to publish. What is here is the pricing and platform detail from the vendor’s own pages, limitations we could state concretely, and alternatives a reviewer confirmed people weigh against it. Tell us if any of it is wrong.

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