ArteraAI Prostate AI
Artera · artera.ai ↗
AI test that analyzes digitized biopsy pathology images to give prostate and breast cancer prognostic results.
PricingUnverified · not published or not confirmed (checked 2026-10-14)
Ranked in
Last checked2026-10-14
AI status
AI product On FDA AI-enabled device list (DEN240068) · source
Compliance profile
| Field | Status | Detail | Source | Checked |
|---|---|---|---|---|
| FDA | Verified | De Novo granted · DEN240068 | accessdata.fda.gov | 2026-10-14 |
| HIPAA | Vendor-stated | Vendor states HIPAA compliance support | artera.ai | 2026-10-14 |
| BAA | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| SOC 2 | Vendor-stated | Vendor references a SOC 2 report (not reviewed by us) | artera.ai | 2026-10-14 |
| HITRUST | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| Epic integration | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
Vendor-stated means the claim appears on the vendor’s site; we have not audited it. Unverified means we found no source, which is not a negative finding. Vendors can request a correction.
FDA records
From the FDA AI-enabled medical devices list. Wording follows FDA: 510(k) “cleared”, De Novo “granted”. Clearance applies to the specific indication in the FDA record.
| Number | Device (as listed) | Pathway | Decision date | Panel |
|---|---|---|---|---|
| DEN240068 | ArteraAI Prostate | De Novo granted | 07/31/2025 | Pathology |
| K254115 | ArteraAI Breast | 510(k) cleared | 05/04/2026 | Pathology |
Alternatives
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