Paige
Computational pathology AI from MSK — the first FDA-cleared platform for AI-assisted cancer diagnosis
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About Paige
Paige is a computational pathology company and Memorial Sloan Kettering Cancer Center spinout that made history as the first company to receive FDA clearance for an AI-based primary diagnosis application in pathology and oncology. Founded on exclusive access to MSK's 25+ million pathology slides and decades of expert cancer diagnoses, Paige's AI models are among the most rigorously trained and clinically validated in the field of digital pathology.
Paige's product suite centers on its FDA-cleared FullFocus digital pathology viewer, Paige Prostate (the first FDA-cleared AI for prostate cancer detection), and Paige Breast for breast cancer analysis — all operating on whole slide images from leading pathology scanners. Its AIRI infrastructure delivers over 10 petaFLOPS of GPU compute for large-scale model training and inference, enabling the creation of clinical-grade AI that meets the exacting standards of pathology laboratories and regulatory agencies. Paige also serves the biopharma industry with biomarker discovery platforms, companion diagnostic development, and drug development research services.
Paige is the premier choice for academic medical centers, cancer centers, hospital pathology departments, and biopharma companies that need the highest level of clinical validation and regulatory credentialing in AI-assisted pathology — underpinned by the world's most storied cancer research institution and a track record of regulatory firsts.
Key Features
- FullFocus — FDA 510k-cleared digital pathology image viewer compatible with Leica, Hamamatsu, and Philips scanners
- Paige Prostate — FDA-cleared AI for prostate cancer detection and Gleason grading
- Paige Breast — AI-assisted breast cancer detection and analysis on whole slide images
- First ever FDA clearance for AI in primary pathology diagnosis — historic regulatory milestone
- First CE mark in AI pathology — cleared for clinical use across EU member states
- AIRI infrastructure with 10+ petaFLOPS GPU compute for large-scale model training
- 1.2M+ slide digital archive from Memorial Sloan Kettering for model training
- Biopharma platform for biomarker discovery, companion diagnostics, and drug development
- Scanner-neutral slide viewer compatible with multiple FDA-cleared scanner systems
- Spinout from Memorial Sloan Kettering with exclusive access to MSK's pathology IP and 25M+ slides
Pros
- First FDA clearance for AI in primary pathology diagnosis — a historic regulatory milestone
- First CE mark for AI pathology in Europe — validated for clinical use across EU
- Founded on MSK's 25M+ pathology slides — the richest cancer pathology training set in the world
- AIRI infrastructure with 10+ petaFLOPS — enterprise-grade AI compute at clinical scale
- FullFocus viewer is scanner-neutral with FDA clearances for Leica, Hamamatsu, and Philips
- The most credentialed AI pathology company in terms of regulatory approvals
- Backed by Goldman Sachs, Breyer Capital, and Healthcare Venture Partners
Cons
- Enterprise and institutional access only — not available to small or independent pathology labs
- No published pricing — all contracts negotiated through enterprise procurement
- Requires digital pathology infrastructure — scanners, storage, and LIS integration
- Pathologist review and sign-off still required for all AI-generated results
- Focused on pathology and oncology — not a general medical imaging platform
Pricing
Paige operates exclusively on enterprise contracts with hospital pathology departments, cancer centers, and biopharma companies. There is no published pricing or self-serve option.
Clinical deployments are priced based on institution size, scanner ecosystem, patient volume, and AI modules deployed (FullFocus, Paige Prostate, Paige Breast, etc.). Biopharma partnerships are structured as research service agreements for biomarker discovery, companion diagnostic development, and drug trial tissue analysis.
Contact Paige through paige.ai to arrange an enterprise discovery call and platform demonstration.
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Connect with Paige
Frequently Asked Questions
Paige received the first FDA clearance ever granted for an AI-based clinical application in pathology and oncology. It also received the first CE mark in the space. Paige's FullFocus digital pathology viewer has received additional FDA 510k clearances for use with Leica Aperio, Hamamatsu NanoZoomer, and Philips IntelliSite scanners.
Paige was founded by researchers from Memorial Sloan Kettering (MSK) Cancer Center and secured exclusive access to MSK's 25+ million pathology slides — one of the largest collections of expert-annotated cancer tissue slides in the world. This dataset was foundational to training Paige's AI models.
Paige's primary products include FullFocus (FDA-cleared digital pathology image viewer), Paige Prostate (AI-assisted prostate cancer detection), Paige Breast (breast cancer detection), and a suite of biopharma research tools for biomarker discovery and companion diagnostic development.
Paige's AIRI infrastructure delivers over 10 petaFLOPS of GPU compute power, enabling training and inference of clinical-grade AI models at a scale that few pathology AI companies can match. This allows Paige to process and analyze large volumes of whole slide images rapidly.
Paige serves hospital and academic pathology departments for clinical diagnostics (prostate, breast, and other cancers) and biopharma companies for drug development, biomarker discovery, and companion diagnostic research.
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