Digital pathology
PathAI
Cloud-native digital pathology platform whose AISight Dx image-management system is FDA-cleared for primary diagnosis with specified whole-slide scanner workflows.
Last updated: June 14, 2026
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Digital pathology AI applications for cancer pathology, including Paige Prostate.
Digital pathology
Best fit
Pathology teams evaluating AI support for prostate biopsy review and digital pathology workflows.
- Primary use case
- AI-assisted digital pathology and prostate cancer detection support
- Audience
- Pathology labs and cancer diagnostic teams
- Risk level
- High
- Pricing signal
- Enterprise pricing; request current terms.
- Official sources
- 3 official sources
Compare within workflow: Digital pathology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA De Novo authorized software device for assisting pathologists with prostate cancer detection in scanned whole-slide images. |
|---|---|
| Review route | De Novo DEN200080. |
| Intended use | Assists pathologists by highlighting foci suspicious for cancer during review of digitized prostate biopsy whole-slide images, within scanner and workflow limits. |
| Verification note | Confirm the exact Paige Prostate product, scanner compatibility, slide preparation, lab validation, pathologist oversight, and current U.S. versus non-U.S. claims. |
| Source | www.accessdata.fda.gov / cdrh_docs / reviews |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Paige as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact Paige product, scanner, tissue type, and intended use, especially for prostate workflows that have FDA-authorized claims. |
|---|---|
| Privacy | Review whole-slide image storage, cloud processing, LIS links, access controls, retention, and any secondary-use terms before diagnostic deployment. |
| Evidence | Validate performance in the local lab across scanner, stain, tissue preparation, case mix, pathologist workflow, and cancer-prevalence differences. |
| Workflow | Best used as pathologist-supervised digital pathology support where suspicious regions, exceptions, and final diagnostic responsibility remain reviewable. |
Where Paige fits
Paige describes AI applications for cancer pathology and a prostate suite for detection and diagnosis support.
Not for: Use beyond authorized indications, scanners, or pathologist-supervised review.
What to verify before using Paige
- FDA authorization and exact intended use for the selected product.
- Scanner and slide preparation compatibility.
- Pathologist workflow and responsibility.
- Validation evidence for your lab population.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
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