Digital pathology
Hologic Genius Digital Diagnostics
FDA-cleared digital cytology system combining volumetric imaging, Genius Cervical AI, image management, and cytologist or pathologist review.
Last updated: June 14, 2026
Back to directoryPathAI medical AI product profile
Cloud-native digital pathology platform whose AISight Dx image-management system is FDA-cleared for primary diagnosis with specified whole-slide scanner workflows.
Digital pathology
Best fit
Labs moving from glass slide review to digital pathology that need governed image management, pathologist collaboration, LIS integration, and a controlled path to AI algorithm adoption.
- Primary use case
- FDA-cleared digital pathology image management, whole-slide viewing, LIS-connected case workflow, AI algorithm access, quality control, and lab collaboration
- Audience
- Anatomic pathology labs, reference labs, health systems, academic medical centers, and biopharma pathology teams
- Risk level
- High
- Pricing signal
- Enterprise AP laboratory and biopharma pricing; request current scanner, LIS, hosting, algorithm, implementation, and support terms.
- Official sources
- 8 official sources
Compare within workflow: Digital pathology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared Class II digital pathology image viewing and management software for primary diagnosis in clinical settings. |
|---|---|
| Review route | 510(k) K243391 for AISight Dx, regulation number 864.3700, product code QKQ. |
| Intended use | Supports digital pathology image viewing and management for pathologist-reviewed workflows; scanner, display, software version, and label conditions must match the cleared configuration. |
| Verification note | Confirm current AISight Dx labeling, supported scanners such as Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX, any later scanner expansions or PCCP changes, LIS integration, and which AI applications remain research use only. |
| Source | www.accessdata.fda.gov / scripts / cdrh |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating PathAI as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Separate AISight Dx image-management clearance from AISight research workflows, third-party algorithms, PathAI AI Product Solutions, ArtifactDetect, TumorDetect, and biopharma tools before allowing diagnostic use. |
|---|---|
| Privacy | Review cloud slide storage, LIS integration through AISight Link, PHI and metadata flow, user roles, audit logs, retention, support access, vulnerability process, BAA or DPA terms, and customer data-use limits. |
| Evidence | Validate primary-diagnosis viewing performance, scanner compatibility, image quality, lab population fit, algorithm-result review, pathologist workload, and any AI claims in the exact deployment setting. |
| Workflow | Best governed as a pathologist-reviewed digital pathology IMS with explicit lab validation, signout responsibility, scanner and LIS controls, downtime procedures, and separation of diagnostic versus RUO algorithm outputs. |
Where PathAI fits
PathAI describes AISight Dx as a cloud-native digital pathology image-management system cleared for primary diagnosis in clinical settings; FDA records list K243391 for AISight Dx as digital pathology image viewing and management software, while PathAI product pages separately flag research-use AI tools and describe AISight Link LIS integration.
Not for: Autonomous diagnosis, unsupported scanner or display configurations, treating research-use AISight algorithms as diagnostic tools, or deploying without laboratory validation and pathologist signout controls.
What to verify before using PathAI
- Whether the deployment is AISight, AISight Dx, AISight Link, an AI Product Solution, ArtifactDetect, TumorDetect, or another workflow with a different intended use.
- FDA 510(k) K243391 status, CE-IVD status, cleared scanner compatibility, display requirements, software version, PCCP coverage, and whether the planned primary-diagnosis workflow matches labeling.
- How whole-slide images, LIS messages, PHI, case metadata, algorithm results, annotations, support access, retention, and audit logs are handled under BAA, DPA, privacy, and security terms.
- Local validation for scanner fleet, stain quality, slide types, image quality, pathologist signout, downtime procedures, AI result review, false reassurance, and exception handling.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.pathai.com / aisightdx-digital-pathology-solution
- www.pathai.com / ap-lab-solutions
- www.pathai.com / resources / pathai-receives-fda-clearance-for-aisight-dx-platform-for-primary-diagnosis
- www.pathai.com / resources / pathai-launches-aisight-linke-to-support-integration-solutions-for-laboratory-customers-and-biopharma-partners
- www.pathai.com / artifactdetect
- www.pathai.com / tumordetect
- www.pathai.com / policies-and-notices
- www.accessdata.fda.gov / scripts / cdrh
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