Perimeter’s ‘Claire’ Becomes First FDA-Approved AI Imaging Device for Breast Cancer Surgery

Perimeter Medical Imaging AI, Inc. has received premarket approval (PMA) from the U.S. Food and Drug Administration for Claire, an AI-enabled imaging system designed for use during breast-conserving surgery. 

The device supports intraoperative assessment of tumour margins and aims to help surgeons identify cancer that may be difficult to detect during surgery. The technology previously received Breakthrough Device designation from the FDA.

Claire, formerly known as the Perimeter OCT B-Series with ImgAssist AI 2.0, combines the company’s artificial intelligence technology with patented wide-field optical coherence tomography (OCT) imaging. 

The system enables high-resolution, real-time evaluation of excised tumour margins and delivers imaging resolution about ten times higher than standard X-ray and ultrasound at an imaging depth of approximately 2 mm, which is considered clinically relevant for breast cancer margin assessment.

The AI engine was trained using a proprietary library of more than two million OCT images of breast tissue. 

During surgery, the system highlights areas of concern so surgeons can decide whether additional tissue removal is required before completing the procedure.

Results from a pivotal clinical trial supporting the approval showed an 88.1% margin accuracy and a statistically significant reduction in residual cancer compared with standard care. The study was led by Alastair Thompson at Baylor College of Medicine.

Repeat surgeries occur in about 20% of breast-conserving procedures in the United States. The approval marks the first commercial use of Perimeter’s OCT-AI imaging platform.