# FDA Grants Premarket Approval to AI-Enabled OCT System for Real-Time Breast Cancer Margin Assessment During Lumpectomy

> fda · REPORTED · 2026-07-29

The FDA granted premarket approval to an AI-enabled optical coherence tomography system designed to assess breast cancer surgical margins in real time during lumpectomy, with the goal of helping surgeons reduce the need for repeat operations and improve patient outcomes.

About AI-OCT Lumpectomy Margin Assessment Device: This AI-powered intraoperative imaging device uses optical coherence tomography to give surgeons real-time visualization of breast cancer margins during lumpectomy procedures, targeting the significant rate of re-excision surgeries in early-stage breast cancer.

- Company: AI-OCT Lumpectomy Margin Assessment Device
- Sector: medical devices
- Primary source: https://www.targetedonc.com/view/fda-grants-premarket-approval-to-ai-enabled-system-for-breast-cancer-margin-assessment

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