First AI-Enabled Imaging Device for Breast Cancer Surgery Granted FDA Premarket Approval
The U.S. Food and Drug Administration (FDA) has granted premarket approval to Claire, an AI-enabled imaging device designed to assess of intraoperative breast cancer margins. The device, previously called the Perimeter OCT B-Series with ImgAssist AI 2.0, had received a prior Breakthrough Device designation from the FDA.
Claire assists surgeons in detecting difficult-to-see tumors during breast-conserving surgery, helping to reduce the need for re-operations due to residual disease. The device uses wide-field optical coherence tomography, providing 10-fold higher resolution than standard X-ray and ultrasound, with an imaging depth of 2 mm, it also incorporates a proprietary AI detection algorithm trained on more than 2 million breast tissue images to evaluate the sub-surface microstructure for signs of residual disease. This enables surgeons to determine intraoperatively whether additional tissue should be removed before completing the procedure.
"Despite progress in breast cancer treatment, intra-operative margin assessment remains challenging, often leading to excess removal of healthy tissue, re-operations, and anxiety for patients as they await pathology results," said Alastair Thompson, BScHons, MBChB, MD, FRCSEd, FACS, Surgeon and Professor, Section Chief of Breast Surgery, Olga Keith Wiess Chair of Surgery at Baylor College of Medicine, Breast Cancer Program Leader at the Dan L Duncan Comprehensive Cancer Center, in a statement. Dr. Thompson was the primary principal investigator of the pivotal trial that supported Claire's premarket approval application. "Claire has the potential to become a new standard in breast surgical care, helping reduce re-excisions while improving patient outcomes."
Data from each procedure performed with the device will also be used to further refine the AI system and improve patient outcomes.
As part of the premarket approval, the FDA authorized a predetermined change control plan allowing future AI enhancements to Claire without additional FDA review.
Supporting Data
Findings from Claire’s pivotal trial were presented at the 2025 American Society of Breast Surgeons Annual Meeting (Abstract 2038296). The prospective, multicenter, randomized, controlled trial evaluated the use of Claire during lumpectomy to address positive pathologic margins following standard intraoperative assessments vs standard assessments alone. The primary endpoint was the occurrence of at least one unaddressed positive margin per subject in the device arm.
A total of 613 women with biopsy-confirmed breast carcinoma were enrolled in the study between January 25, 2022, and September 23, 2024; 208 women were randomly assigned to the device arm, with 206 evaluable for effectiveness.
Standard-of-care assessments evaluated 1,735 margins and left 56 margins positive and unaddressed in 35 patients (17%) in the device arm. The AI-assisted device evaluated 1,230 margins and identified 115 (9.3%) that required additional cutting. Claire correctly detected residual disease in 14 of the 35 patients (40%), enabling complete clearance of residual disease in seven patients (20%). Only 28 patients (13.5%) were left with unaddressed positive margins (P = .005).
The average total lumpectomy tissue volume excised in the device arm was 74 cm3, of which 76.4% came from the primary lumpectomies, 19.9% from standard-of-care additional cuts, and 3.8% from device-directed shaves.
Overall margin accuracy was 88.1% and the study met its super-superiority performance goal.
No unanticipated device-related or serious adverse events were reported.
DISCLOSURE: For disclosures from the study authors, visit breastsurgeons.org.
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