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Back to directoryArteraAI Prostate medical AI product profile
Multimodal AI prostate cancer test that analyzes digital pathology and clinical data to support risk stratification and treatment-personalization decisions.
Precision medicine and data
Best fit
Prostate cancer programs that need an FDA-authorized, clinician-ordered AI risk-stratification input tied to pathology images, clinical data, and guideline-aware decision workflows.
- Primary use case
- AI-enabled digital pathology and clinical-data test for prostate cancer prognosis, therapy-benefit prediction, and treatment-intensity personalization
- Audience
- Urologists, radiation oncologists, pathologists, precision-oncology teams, tumor boards, and health systems evaluating prostate cancer risk stratification
- Risk level
- High
- Pricing signal
- Clinical test coverage, Medicare, commercial payer, and partnership terms vary; verify current ordering, coverage, and laboratory billing details.
- Official sources
- 5 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
product-specific source-backed lens: These product-specific signals summarize what the cited sources imply before treating ArteraAI Prostate as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact ArteraAI Prostate version and indication against FDA De Novo DEN240068, CLIA/CAP lab status, scanner compatibility, NCCN-referenced use, CE/IVDR status, and partner-specific implementations before clinical use. |
|---|---|
| Privacy | Review the HIPAA notice, privacy policy, ordering workflow, lab data handling, de-identification, retention, report access, and payer or partner data flows because the test uses pathology images and clinical information. |
| Evidence | Check validation cohorts, Phase 3 trial evidence, population representation, endpoint definitions, scanner or specimen constraints, and whether the report output supports the intended decision in the local tumor board workflow. |
| Workflow | Use as a clinician-ordered precision-oncology input with urology, radiation oncology, pathology, and patient shared-decision review before treatment intensification, active surveillance, salvage therapy, or metastatic prostate workflows are changed. |
Where ArteraAI Prostate fits
Artera describes ArteraAI Prostate as a multimodal AI test using digital pathology images and clinical data to estimate long-term outcomes and therapy benefit; official clinician materials cite NCCN guideline positioning, FDA documentation covers De Novo DEN240068 for ArteraAI Prostate, and partner materials describe a Tempus-integrated mHSPC clinical launch.
Not for: Unsupervised treatment selection, use outside the authorized or validated population, or replacing oncologist, urologist, pathologist, and patient shared decision-making.
What to verify before using ArteraAI Prostate
- Whether the patient population matches the localized, non-metastatic, post-radical-prostatectomy, or metastatic hormone-sensitive prostate workflow being considered.
- FDA De Novo scope, scanner compatibility, CLIA/CAP laboratory status, NCCN guideline references, and any CE/IVDR or partner availability for the deployment region.
- How biopsy or prostatectomy slide images, clinical variables, PHI, ordering data, reports, retention, de-identification, and patient notices are handled.
- How clinicians interpret prognostic risk, predicted therapy benefit, uncertainty, payer coverage, and shared-decision documentation before changing treatment intensity.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- artera.ai / for-clinicians
- artera.ai / news / artera-receives-u-s-fda-de-novo-marketing-authorization-for-ai-digital-pathology-software-revolutionizing-prostate-cancer-care
- www.accessdata.fda.gov / cdrh_docs / pdf24
- artera.ai / hipaa-notice
- www.tempus.com / news / pr
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