Perimeter Medical Imaging AI's Claire Earns First FDA PMA for AI-Enabled Breast Cancer Margin Assessment
SHERIDAN, WYOMING - April 03, 2026 - Perimeter Medical Imaging AI has secured FDA premarket approval (PMA) for Claire, making it the first AI-enabled imaging device cleared in the United States for intraoperative breast cancer margin assessment during lumpectomy procedures. Claire, previously marketed as the Perimeter OCT B-Series with ImgAssist AI 2.0, holds FDA Breakthrough Device designation and targets an estimated 300,000 annual U.S. breast-conserving surgeries where residual disease forces re-operations in roughly one in five cases. The approval positions Perimeter to launch a nationwide commercial rollout in the weeks following clearance, converting a clinical trial asset into a revenue-generating platform with expansion potential across additional cancer indications.