Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its AI‑assisted wide‑field optical coherence tomography device designed to image surgical margins during breast‑conserving surgery. The PMA clearance authorizes Claire for real‑time, high‑resolution imaging of excised tissue to help surgeons identify residual tumor at the margins. Claire combines machine vision algorithms with optical imaging to present interpretable margin maps in the operating room. The regulatory approval positions the device to reduce re‑operation rates and shorten pathology turnaround, and it establishes an FDA precedent for AI‑enabled intraoperative margin assessment.