Claire OCT System
Perimeter Medical Imaging AI, Inc.
FDA
AI-enabled wide-field optical-coherence-tomography system that images excised
breast-tissue specimens in the operating room during breast-conserving
surgery. The scanner produces volumetric, cross-sectional images of the
specimen margin to a depth of about 2 mm at up to 50 µm resolution, and a
convolutional-neural-network computer-aided-detection feature (ImgAssist 2.0)
marks focal regions suspicious for cancer for the surgeon to review
concurrently with standard-of-care margin assessment. FDA granted Class III
premarket approval (P250008) with a Predetermined Change Control Plan on
3 March 2026 on the strength of a prospective, multi-centre pivotal trial
whose primary endpoint was a within-arm reduction in the number of patients
left with an unaddressed positive margin.
