Perimeter Medical Imaging AI received FDA premarket approval for Claire, an AI‑driven wide‑field optical coherence tomography system designed to image excised breast tissue margins during surgery. The clearance covers the device’s real‑time imaging and AI algorithms intended to reduce re‑operation rates by identifying residual cancer at the margins. Claire pairs high‑resolution optical coherence tomography with machine learning to present surgeons with interpretable margin maps intraoperatively. Perimeter said the approval followed clinical validation demonstrating improved margin detection over standard visual and palpation assessments. Regulatory clearance positions Claire for commercial rollout in breast‑conserving surgery and signals growing FDA receptivity to combined hardware‑AI surgical aids that aim to shorten care pathways and lower re‑excision rates.