Digital pathology
Paige
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Last updated: June 5, 2026
Back to directoryPathPresenter medical AI product profile
Enterprise digital pathology image-management system with a cleared clinical viewer and workflow modules for clinical care, consultations, research, education, and AI model access.
Digital pathology
Best fit
Pathology groups that need a vendor-agnostic IMS foundation with clinical viewing, remote collaboration, LIS/scanner interoperability, and a governed way to evaluate pathology AI models.
- Primary use case
- Digital pathology image management, FDA-cleared clinical viewing, remote consultations, education, biorepository workflows, and access to third-party AI models
- Audience
- Hospital pathology departments, academic medical centers, reference labs, biorepositories, and digital pathology programs evaluating image-management and AI-ready workflows
- Risk level
- High
- Pricing signal
- Enterprise image-management, clinical viewer, education, consultation, and biorepository pricing varies by module and deployment; request current terms.
- Official sources
- 8 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 PathPresenter as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Separate the FDA-cleared Clinical Viewer configuration from ConsultConnect, education, biorepository, third-party AI models, other scanners/displays, non-U.S. regions, and research-use workflows. |
|---|---|
| Privacy | Verify contractual HIPAA/BAA or DPA terms, cloud versus hybrid storage, de-identification requirements, user roles, remote consult sharing, audit logs, retention, and AI model data pathways before uploading patient slides. |
| Evidence | Review FDA 510(k) materials, local scanner/display validation, pathologist viewer performance, consult turnaround, AI model validation, and any institution-specific V&V results before clinical signout use. |
| Workflow | Best evaluated as a digital-pathology operating layer where image management, primary viewing, remote consults, education, research, and AI model testing each have explicit governance boundaries. |
Where PathPresenter fits
PathPresenter describes an enterprise image-management and workflow platform for digital pathology, clinical care, remote consultations, research, education, biorepository management, and AI model access; its public materials state that the Clinical Viewer received FDA 510(k) clearance for primary diagnosis only with specified Hamamatsu scanner files and a Barco display configuration.
Not for: Assuming every AI model, scanner, display, file format, region, or research workflow inherits the cleared primary-diagnosis scope.
What to verify before using PathPresenter
- Whether the purchase covers Clinical Viewer, ConsultConnect, education, biorepository management, AI integrations, or a combination of modules.
- FDA 510(k), CE-IVDR, scanner, display, file format, region, and intended-use limits for primary diagnosis and any AI-supported workflow.
- Whole-slide image storage, cloud or hybrid architecture, LIS integration, remote-access controls, de-identification, support access, retention, and BAA or DPA terms.
- How pathologists launch AI models, review AI outputs, manage consults, document exceptions, and retain final signout responsibility.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.pathpresenter.com
- www.pathpresenter.com / clinical-care
- www.pathpresenter.com / research
- www.pathpresenter.com / fda-510k-clearance
- www.accessdata.fda.gov / scripts / cdrh
- www.pathpresenter.com / about-pathpresenter
- www.pathpresenter.com / terms
- www.pathpresenter.com / privacy-policy
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