Company Spotlight: ArteraAI Breast - Predicting Metastasis from H&E Slides

We unpack the FDA clearance letter for ArteraAI Breast, a software-only device designed to predict 5- and 10-year metastasis risks from standard pathology slides. We explore the specific patient population it targets, the regulatory significance of its Predetermined Change Control Plan, and why an administrative clearance letter doesn't include performance data.

Key points

• ArteraAI Breast is an FDA-cleared, software-only device that analyzes whole slide images of H&E stained tissue alongside patient age, tumor size, and nodal status.
• It outputs 5- and 10-year risks of distant metastasis and an ArteraAI risk score for a specific cohort: adult patients with early-stage, HR+/HER2-, N0 or N1 invasive breast cancer.
• The FDA clearance includes a Predetermined Change Control Plan, allowing the company to make certain device modifications without a new 510(k) submission.
• Because this document is the administrative clearance letter and not the full 510(k) summary, it does not name the predicate device or provide performance testing numbers.
• The clearance mandates strict adherence to the Quality Management System Regulation, including specific ISO 13485 clauses for design controls and corrective actions.

Source: FDA 510(k) summary K254115: ArteraAI Breast (Artera) - U.S. Food and Drug Administration, 2026

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Artera (artera.ai) · Product: ArteraAI Breast · FDA 510(k) K254115

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-arteraai-breast-predicting-metastasis-from-h-e-slide-31d8ec