Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑enabled wide‑field optical coherence tomography device that provides real‑time, high‑resolution imaging of excised breast tissue margins during breast‑conserving surgery. The approval aims to reduce re‑operation rates by enabling immediate margin assessment in the OR. Claire combines optical coherence tomography with machine‑learning algorithms to identify difficult‑to‑see cancer at the specimen surface and was reviewed under the agency’s regulatory pathways. Perimeter positioned the approval as a commercial accelerant for intraoperative margin assessment and a potential workflow alternative to frozen section and delayed pathology. Hospitals and surgical centers will evaluate Claire for integration into perioperative workflows; payers and procurement groups will watch real‑world data on re‑operation reductions and cost‑effectiveness as the device scales.