Paige / paige.ai
FDA-authorised AI pathology platform for cancer detection that analyses digital pathology slides for prostate cancer and other oncology applications, assisting pathologists in diagnosis.
Pricing
Free
Free plan
No
Category
Developer Tools
Platforms
2
Free plan
No
API access
No
Open source
No
Platforms
2
Paige is an AI pathology company with an important regulatory distinction: Paige Prostate, its flagship product for detecting prostate cancer in digital pathology slides, received the first ever FDA De Novo authorisation for an AI-based clinical decision support tool in digital pathology in 2021. This regulatory milestone distinguishes Paige from AI pathology companies with pre-market tools.
The AI analyses prostate biopsy slides stained with H&E (haematoxylin and eosin) to detect and classify cancer tissue, assisting pathologists by highlighting suspicious regions and providing a confidence score. This computer-aided detection approach helps pathologists identify cancer they might otherwise miss, particularly in complex cases where small foci of cancer may be difficult to spot.
Studies published with Paige's technology have shown detection sensitivity improvements — AI-assisted pathologists catch more cancers than either AI alone or pathologists alone, demonstrating the clinical value of AI augmenting rather than replacing pathologist expertise.
Paige is expanding beyond prostate to breast, colorectal, and other cancer types, building on the FDA-authorisation foundation to establish clinical AI pathology across oncology. The company has partnerships with major academic medical centres and pathology laboratories.
For pathology labs evaluating AI, Paige's FDA authorisation is a critical differentiator for clinical deployment. Uncleared AI tools cannot legally be used as clinical decision support in the United States, making regulatory status a prerequisite for clinical use.
Paige AI 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.
Recent YouTube videos cached from the backend so this page stays fast and fresh.
The capabilities that matter most for teams evaluating Paige AI.
FDA De Novo authorised AI for detecting and classifying prostate cancer in digital H&E pathology slides — the first FDA-authorised AI clinical decision support tool for digital pathology.
Highlights suspicious regions on digital pathology slides with confidence scoring to assist pathologist review, improving cancer detection sensitivity in clinical studies.
Published studies demonstrating improved prostate cancer detection sensitivity with AI-assisted pathologists versus unaided pathologists or AI alone.
Enterprise licensing to health systems and pathology labs. No public pricing or individual access.
Model
Enterprise
Starting price
Free
Free trial
No
PathAI (covered, rank 371) provides AI pathology for pharmaceutical research alongside clinical tools. Proscia provides digital pathology workflow AI. Hamamatsu and Aperio scanning systems include AI features. Visiopharm provides image analysis for research pathology.
A side-by-side look at the closest alternative in this category.
Key facts about model providers, platforms, and team support.
Model Provider
Paige
Platforms
Web, LIS integrated
Deployment
Enterprise, SaaS
Integrations
Aperio, Hamamatsu, Philips, Epic, API
Team Collaboration
No
Launch Year
2021
Compliance signals and data-handling notes as reported by the vendor.
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 with medical device security standards. FDA authorised for specific clinical indications.
Editorial Verdict
Paige is the leading FDA-authorised AI pathology platform for prostate cancer, essential for pathology labs that require FDA clearance for clinical AI deployment.
Last verified July 24, 2026.
Enterprise licensing to health systems and pathology labs. No public pricing or individual access.
Enterprise and pharmaceutical partner licensing. No public pricing or individual access.
HIPAA compliant with BAA. FDA De Novo authorisation (Paige Prostate). ISO 13485 medical device quality management. Enterprise data handling agreements.
HIPAA compliant with BAA. ISO 13485. FDA clearance for specific indications. Enterprise data handling agreements.
Digital pathology slide data processed under HIPAA BAA with medical device security standards. FDA authorised for specific clinical indications.
Digital pathology slide data processed under HIPAA BAA. FDA clearance for clinical use is indication-specific — review regulatory status for each intended use.
Verified reviews from signed-in users, stored in the backend and averaged into this tool's rating.
Sign in to rate Paige AI and leave a review.
No other reviews yet — be the first to share how this tool performs in practice.
