# FDA Grants First PMA to AI-Enabled Imaging Device for Breast Cancer Surgery

> fda · REPORTED · 2026-03-03

The FDA granted premarket approval to Perimeter Medical Imaging AI's Claire device, making it the first FDA-approved AI-enabled intraoperative imaging device for use in breast cancer surgery. A predetermined change control plan was also authorized, allowing future AI enhancements without requiring additional FDA submissions.

About Perimeter Medical Imaging AI: Perimeter Medical Imaging AI develops AI-powered optical coherence tomography imaging systems designed to help surgeons assess surgical margins in real time during breast cancer procedures.

- Company: Perimeter Medical Imaging AI
- Sector: medical devices
- Primary source: https://www.cancernetwork.com/view/fda-grants-pre-market-approval-to-ai-device-for-breast-cancer-surgery

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.