PathAI
PathAI / pathai.com
AI-powered pathology platform that analyses whole-slide digital pathology images to support cancer diagnosis, drug development, and clinical trial patient selection.
Pricing
Free
Free plan
No
Category
Developer Tools
Platforms
2
Free plan
No
API access
No
Open source
No
Platforms
2
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What is PathAI?
PathAI is an AI pathology company that applies deep learning to digital pathology — analysing whole-slide images of tissue biopsies at cellular resolution to support cancer diagnosis, clinical trial patient selection, and drug development biomarker discovery. Pathology is a field where AI has demonstrated significant capability, as the analysis of cellular patterns in tissue images is both highly visual and highly repetitive, making it well-suited to deep learning.
The platform analyses H&E stained tissue slides — the standard pathology preparation — to identify tumour regions, cell types, cellular density, and other morphological features that pathologists use for diagnosis and prognosis. AI quantification of these features is more consistent than manual pathologist analysis across large sample sets.
For pharmaceutical companies running clinical trials, PathAI's biomarker analysis can identify which patient subgroups in a trial responded to a treatment based on pathology slide features. This retrospective biomarker discovery from existing tissue samples can identify which patients are most likely to benefit from a drug, supporting companion diagnostic development.
PathAI works with partners including Bristol Myers Squibb, AstraZeneca, and Gilead Sciences on drug development programmes, and with health systems including the Mayo Clinic for clinical AI pathology tools.
The FDA-cleared tools for specific indications provide clinical-grade pathology AI for deployment in diagnostic workflows where regulatory clearance is required.
How PathAI works
PathAI runs as computer vision software built around image and data workflows. Users typically start with a prompt, upload, or connected data source, and the underlying model handles the heavy lifting before returning a result you can refine or export. It's available on web and lis integrated.
Watch PathAI in action
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What makes it worth shortlisting
The capabilities that matter most for teams evaluating PathAI.
Whole-slide image analysis
Analyses entire high-resolution pathology slides at cellular resolution for tumour identification, cell type classification, and morphological feature quantification.
Biomarker discovery
Analyses tissue slides from clinical trial patients to identify morphological biomarkers that correlate with treatment response for companion diagnostic development.
Consistent quantification
Provides reproducible quantitative measurements across large tissue sample sets, reducing the inter-pathologist variability that limits reliability of manual morphological analysis.
Best use cases
Who should use it
Pros
- Demonstrable accuracy in specific cancer diagnosis tasks on large pathology slide datasets
- Pharmaceutical partner programme with BMS, AstraZeneca, and Gilead validates clinical credibility
- Consistent quantification across large sample sets improves on inter-pathologist variability
- FDA-cleared tools for specific clinical indications
Cons
- Enterprise and pharmaceutical partner model — not accessible to individual pathology labs
- Regulatory clearance is indication-specific — clinical use requires FDA-cleared indications only
- ROI case requires high-volume pathology operation or significant clinical trial programme
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Is it worth the price?
Enterprise and pharmaceutical partner licensing. No public pricing or individual access.
Model
Enterprise
Starting price
Free
Free trial
No
Tools like PathAI
Paige AI is a direct competitor with similar cancer pathology AI and FDA clearance. Proscia provides digital pathology workflow AI. Hamamatsu's NDP View includes AI features. Visiopharm is an image analysis competitor for research pathology.
PathAI vs Paige AI
A side-by-side look at the closest alternative in this category.
PathAI
PathAI
Paige AI
Paige
Enterprise and pharmaceutical partner licensing. No public pricing or individual access.
Enterprise licensing to health systems and pathology labs. No public pricing or individual access.
HIPAA compliant with BAA. ISO 13485. FDA clearance for specific indications. Enterprise data handling agreements.
HIPAA compliant with BAA. FDA De Novo authorisation (Paige Prostate). ISO 13485 medical device quality management. Enterprise data handling agreements.
Digital pathology slide data processed under HIPAA BAA. FDA clearance for clinical use is indication-specific — review regulatory status for each intended use.
Digital pathology slide data processed under HIPAA BAA with medical device security standards. FDA authorised for specific clinical indications.
- Demonstrable accuracy in specific cancer diagnosis tasks on large pathology slide datasets
- Pharmaceutical partner programme with BMS, AstraZeneca, and Gilead validates clinical credibility
- Consistent quantification across large sample sets improves on inter-pathologist variability
- FDA-cleared tools for specific clinical indications
- First FDA De Novo authorisation for AI clinical pathology — critical regulatory differentiator for clinical deployment
- Published clinical evidence shows improved cancer detection with AI-assisted pathologists
- Expanding cancer type coverage builds on the regulatory foundation for prostate cancer
- Academic medical centre partnerships provide credible clinical reference implementations
- Enterprise and pharmaceutical partner model — not accessible to individual pathology labs
- Regulatory clearance is indication-specific — clinical use requires FDA-cleared indications only
- ROI case requires high-volume pathology operation or significant clinical trial programme
- Enterprise licensing only — not accessible to individual pathologists or small labs
- FDA authorisation is indication-specific — Paige Prostate is cleared; other cancer types are in different regulatory stages
- Clinical AI pathology adoption requires significant workflow integration and pathologist training investment
Technical & deployment info
Key facts about model providers, platforms, and team support.
Model Provider
PathAI
Platforms
Web, LIS integrated
Deployment
Enterprise, SaaS
Integrations
Epic, Cerner, Aperio, Hamamatsu, API
Team Collaboration
No
Launch Year
2019
Security & privacy
Compliance signals and data-handling notes as reported by the vendor.
HIPAA compliant with BAA. ISO 13485. FDA clearance for specific indications. Enterprise data handling agreements.
Digital pathology slide data processed under HIPAA BAA. FDA clearance for clinical use is indication-specific — review regulatory status for each intended use.
What users are saying
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Common questions about PathAI
Editorial Verdict
Should you use PathAI?
PathAI is the leading AI pathology platform for pharmaceutical companies running oncology clinical trials and for pathology labs wanting AI-assisted cancer diagnosis with FDA-cleared tools for specific indications.
Last verified July 24, 2026.