Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑powered wide‑field optical coherence tomography device that provides surgeons with high‑resolution, real‑time imaging of excised breast tissue margins. The clearance positions Claire to reduce re‑operation rates by enabling intraoperative detection of residual cancer that is difficult to see with standard pathology sampling. The device combines an optical imaging modality with machine learning algorithms to help surgeons assess margins during breast‑conserving procedures. Perimeter said the approval will support commercial roll‑out and could alter surgical workflows by shortening time to margin assessment and decreasing patient re‑intervention rates. The decision also underscores the FDA’s growing engagement with AI‑enabled diagnostic tools and the push to integrate imaging and analytics into the operating room.