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PathAI

First AI pathology platform FDA-cleared for primary diagnosis, now deployed nationwide via Labcorp

4.3 Healthcare AI
4.3 Very good 4.3
Genuine FDA clearance for primary diagnosis, not just an assistive tool Enterprise quote-based pricing requires a sales conversation, no published rates
Reviewed by Challenging Voice Editorial · Updated Jul 2026 How we rate
PricingContact for Pricing
Free planNo
CompanyPathAI
PlatformsAPI, Web
CategoryHealthcare AI
Founded2016
Last reviewedJul 2026

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Overview

PathAI, founded by Andrew Beck, applies AI to digital pathology, analyzing tissue slide images to assist pathologists in diagnosing disease, with its AISight Dx platform aimed at making pathology diagnosis faster and more consistent across labs and hospital systems.

The company reached a genuine regulatory milestone when AISight Dx received FDA 510(k) clearance for primary diagnosis in clinical settings in June 2025, building on an earlier 2022 clearance, and the FDA clearance included a Predetermined Change Control Plan letting PathAI validate future updates without new submissions each time. In February 2026, Labcorp expanded its collaboration with PathAI to deploy AISight Dx across its national network of pathology labs.

Enterprise pricing is quote-based around lab volume and deployment scope, requiring a direct sales conversation rather than published self-serve rates. For a pathology lab or hospital system that wants an FDA-cleared AI platform for primary diagnosis deployed at national scale, PathAI's AISight Dx addresses that directly.

Key features

  • AISight Dx analyzes digital pathology slide images to assist diagnosis
  • FDA 510(k) clearance for primary diagnosis in clinical settings, June 2025
  • Predetermined Change Control Plan allows faster future software updates
  • Expanded Labcorp collaboration deploying nationwide as of February 2026
  • FDA Breakthrough Device Designation for PathAssist Derm dermatopathology tool
  • $315M raised across five funding rounds

Screenshots & demo

Demo video

Screenshots

PathAI screenshot 1

Pricing

PathAI uses custom pricing. Contact their team for a quote based on your needs.

  • Pricing modelContact for Pricing
  • Starting priceCustom
  • Free planNo
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Pricing is provided as a guide. Check the official site for the latest plans.

Pros & cons

Pros

  • Genuine FDA clearance for primary diagnosis, not just an assistive tool
  • Predetermined Change Control Plan speeds up future regulatory-approved updates
  • National-scale deployment through Labcorp validates real clinical trust
  • Expanding into additional specialties like dermatopathology broadens its reach

Cons

  • Enterprise quote-based pricing requires a sales conversation, no published rates
  • Built specifically for pathology labs, not applicable to other clinical specialties
  • Regulatory-cleared medical device status means slower iteration than software-only tools

How it compares

ToolRatingFreeFromBest known for
PathAI (this tool)4.3No—AISight Dx analyzes digital pathology slide images to assist diagnosis
Proscia4.3No—FDA-cleared for primary clinical diagnosis in AP-Dx
Paige4.1No—Paige Alba AI co-pilot for digital pathology tissue-slide analysis
Artera4.4No—Multimodal AI trained on digitized biopsy images paired with clinical data

Alternatives to PathAI

4 tools matched to PathAI on what they do, their category and their price.

Frequently asked questions

What is PathAI?
PathAI, founded by Andrew Beck, applies AI to digital pathology, analyzing tissue slide images to assist pathologists in diagnosing disease, with its AISight Dx platform aimed at making pathology diagnosis faster and more consistent across labs and hospital systems.
Is PathAI free?
PathAI does not offer a free plan.
What are the best PathAI alternatives?
The closest matches in the directory are Proscia, Paige, and Artera, compared side by side above.

Reviews

4.3 Editorial rating No reviews yet

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