Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its AI‑augmented wide‑field optical coherence tomography device designed to image excised breast margins intraoperatively. The PMA allows Claire to be used during breast‑conserving surgery to help surgeons detect occult cancer at tissue edges and reduce re‑operation rates. Perimeter’s approval couples hardware imaging with machine‑learning interpretation and signals continued regulator receptivity to integrated AI‑device combinations in surgical oncology. Hospitals and surgical centers will evaluate Claire’s workflows and cost‑benefit versus standard pathology and frozen‑section approaches.