# FDA Grants Premarket Approval for Claire, First AI-Enabled Intraoperative Imaging Device for Breast Cancer Margin Assessment

> fda · REPORTED · 2026-03-04

Dallas-based Perimeter Medical Imaging AI received FDA premarket approval for Claire, the first AI-enabled device cleared in the US to assess breast cancer surgical margins in real time during surgery. The approval is intended to reduce repeat surgeries caused by residual disease at the margins.

About Perimeter Medical Imaging AI: Perimeter Medical Imaging AI develops AI-powered intraoperative imaging systems for breast cancer surgery, enabling real-time assessment of tumor margins to help surgeons achieve clear margins in a single procedure.

- Company: Perimeter Medical Imaging AI
- Sector: oncology
- Primary source: https://www.dmagazine.com/healthcare-business/2026/03/perimeter-medical-receives-fda-approval-for-ai-enabled-imaging-device/

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