Pathology
ArteraAI Breast
Artera, Inc.
Software-only device that analyses scanned H&E whole-slide images of treatment-naive breast resection specimens, together with physician-entered age, tumour size and nodal status, to provide 5- and 10-year risks of distant metastasis and an ArteraAI risk score for adults with HR-positive, HER2-negative, N0 or N1 early-stage invasive breast cancer after surgical resection who are candidates for standard-of-care adjuvant therapy. It is intended to assist physicians with prognostic risk-based decisions alongside other clinicopathological factors.
FDA Submission Metadata
- Submission number
- K254115
- Decision date
- May 2026
- FDA panel
- Pathology
- Product code
- SHW
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals