Digital pathology
Paige
Digital pathology AI applications for cancer pathology, including Paige Prostate.
Last updated: June 5, 2026
Back to directoryRoche navify Digital Pathology medical AI product profile
Enterprise digital pathology software from Roche for pathology case workflow, image management, collaboration, integration, and access to AI-based image analysis algorithms.
Digital pathology
Best fit
Labs standardizing Roche-compatible digital pathology workflows that need scanner interoperability, LIS/PACS integration, cloud or on-prem options, and governed access to image-analysis algorithms.
- Primary use case
- Digital pathology case workflow, whole-slide image viewing, multi-slide review, collaboration, LIS/PACS integration, cloud or on-prem deployment, and access to AI-based image analysis algorithms
- Audience
- Hospital pathology departments, health-system labs, pathology networks, and digital pathology teams evaluating enterprise image-management and AI-ready workflows
- Risk level
- High
- Pricing signal
- Enterprise pathology software, cloud, scanner, middleware, algorithm, and services pricing; request current regional terms from Roche.
- Official sources
- 6 official sources
Compare within workflow: Digital pathology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Roche navify Digital Pathology as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match Roche Digital Pathology Dx, navify Digital Pathology, scanner/display configuration, specimen type, geography, and each AI algorithm to country-specific labeling, FDA 510(k), RUO, or local diagnostic-use status. |
|---|---|
| Privacy | Review Roche digital trust materials, cloud hosting, Amazon S3 storage, encryption, authentication, audit logs, user roles, LIS/PACS data exchange, support access, BAA or DPA terms, and third-party algorithm data paths. |
| Evidence | Validate scanner compatibility, viewer performance, image quality, algorithm accuracy, pathologist workload, LIS/PACS integration, downtime handling, and local specimen variability before clinical use. |
| Workflow | Best governed as an enterprise digital-pathology operating layer where viewing, case collaboration, AI analysis, analytics, and final pathologist signout each have explicit boundaries. |
Where Roche navify Digital Pathology fits
Roche describes navify Digital Pathology as enterprise pathology software for case workflow, multi-slide viewing, annotation, collaboration, cloud or on-prem deployment, scanner interoperability, PACS and navify Pathology Lab Hub integration, and access to AI-based image analysis algorithms through Roche Open Environment. Roche labeling materials describe Roche Digital Pathology Dx as an aid for qualified pathologists reviewing FFPE whole-slide images and state limits for other applications, while FDA records list Roche Digital Pathology Dx 510(k) clearances K232879 and K242783.
Not for: Assuming every scanner, specimen type, algorithm, geography, cloud workflow, or research use is covered by the same diagnostic labeling or FDA clearance.
What to verify before using Roche navify Digital Pathology
- Which deployment is in scope: cloud navify Digital Pathology, on-prem software, Roche Digital Pathology Dx, scanners, navify Pathology Lab Hub, analytics, or algorithm access.
- Country-specific labeling, FDA 510(k) records, scanner/display configuration, FFPE specimen limits, frozen section/cytology exclusions, and whether algorithms are diagnostic or research-use only.
- Cloud versus on-prem architecture, Amazon S3 storage, LIS/PACS integration, authentication, encryption, role access, audit logging, BAA or DPA terms, and retention.
- How pathologists review digital slides, launch AI algorithms, reconcile algorithm outputs, document exceptions, manage downtime, and retain final signout responsibility.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- diagnostics.roche.com / us / en
- diagnostics.roche.com / us / en
- diagnostics.roche.com / us / en
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / scripts / cdrh
- navify.roche.com / gr / en-us
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