The U.S. Food and Drug Administration has approved Claire, an AI-enabled optical coherence tomography imaging device from Perimeter Medical Imaging AI (TSX: PINK). It is the first FDA-approved AI imaging device for breast cancer surgery — a long-awaited milestone for intraoperative cancer detection.
How Claire Works
Claire — previously the Perimeter OCT B-Series — uses ultra-high-resolution optical coherence tomography combined with deep learning to image excised breast tissue in real time during lumpectomy procedures. The system flags suspicious margins so surgeons can re-excise tissue in the same operating-room session instead of calling patients back for second surgeries.
Why It Matters
Roughly 20-35% of lumpectomy patients in the U.S. require a second operation because cancer is found at the margin after initial surgery. Claire targets that gap directly, joining a 1,104-strong list of FDA-cleared radiology AI devices and continuing radiology's dominance of medical AI — about 76% of all FDA-cleared AI medical devices.
Broader AI Imaging Boom
The FDA cleared 72 AI-enabled medical devices in Q4 2025 alone, 55 of them radiology devices, and experts expect a strong 2026 pace. Recent FDA clearance of Subtle Medical's SubtleHD PET and active development at peers across diagnostics shows how AI imaging is moving from screening to interventional applications.
What's Next
Perimeter plans a phased rollout into U.S. breast surgery centers, supported by training and KOL programs, with parallel development of indications in other solid tumors. Reimbursement pathways and ongoing clinical evidence will determine how quickly Claire becomes standard of care.
Reporting based on coverage from Radiology Business, The Imaging Wire and Applied Radiation Oncology.