ArteraAI Breast
An FDA-cleared AI test (May 2026) that reads breast cancer slides to estimate recurrence risk in early hormone-positive disease.
First FDA-cleared digital-pathology-based risk stratification tool for early-stage HR+/HER2- invasive breast cancer, positioned as a faster, cheaper alternative to gene-expression assays.
1.H&E whole-slide images are scanned
- Medicare
- Unknown
Newer test; no Medicare coverage determination had been published at the time of writing. Check the MolDX programme for a current decision.
- Commercial insurance
- unknown
Commercial coverage not yet established.
Sources: CMS Medicare Coverage Database (NCDs and LCDs) · CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
- Notes
- Not available on the NHS; NICE has assessed AI prognostic tools via early value assessments, not TAs.
- NHS England
- Not routinely funded
Sources: NICE search: ArteraAI Breast. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- May 2026ApprovalUS
FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Risk stratification in early-stage HR+/HER2- invasive breast cancer |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Launched May 2026; coverage determinations pending | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"ArteraAI Breast" OR ABSTRACT:"ArteraAI Breast") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about ArteraAI Breast, not a curated reading list.