Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑enabled wide‑field optical coherence tomography device designed to detect cancer at excised breast margins in real time. The clearance covers intraoperative use to help surgeons identify residual tumor and reduce re‑operation rates. Perimeter combines high‑resolution imaging with machine learning to highlight areas suspicious for cancer, offering immediate feedback in the operating room. The approval follows clinical validation data and regulatory submissions that positioned Claire as a surgical adjunct to improve breast‑conserving surgery outcomes. The device’s market entry could accelerate adoption of intraoperative margin assessment tools and shift perioperative workflows for breast cancer surgery.
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