Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑powered wide‑field optical coherence tomography (OCT) device that provides surgeons with real‑time, high‑resolution imaging of excised breast tissue margins. The clearance targets reduction in re‑operation rates by detecting occult tumor at margins during breast‑conserving surgery. Claire combines OCT hardware with machine‑learning algorithms to highlight suspicious tissue and deliver immediate feedback in the operating room. Optical coherence tomography is a label‑free imaging modality that provides micrometer‑scale structural images of tissue; the AI layer is trained to detect pathology patterns correlated with positive margins. Surgeons and hospital systems will weigh the device’s potential to lower repeat surgeries and associated costs against capital and workflow integration; the approval marks a significant regulatory precedent for intraoperative AI‑guided imaging tools.