FDA Approves Claire: AI-Powered Imaging Device for Breast Cancer Surgery

The Food and Drug Administration (FDA) has granted premarket approval to Claire, an AI-enabled imaging device developed by Perimeter Medical Imaging AI, Inc. This marks a significant advancement in breast cancer surgery, offering surgeons a new tool to improve accuracy and potentially reduce the require for repeat operations. Claire is the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment.

How Claire Works

Claire utilizes optical coherence tomography (OCT) combined with artificial intelligence (AI) to provide surgeons with real-time, high-resolution imaging during breast-conserving surgery. The device delivers 10 times higher resolution than standard X-ray and ultrasound at a 2 mm imaging depth – a clinically relevant margin width for breast cancer assessment. It helps detect difficult-to-see cancer cells that might otherwise be missed during surgery. The technology was trained on Perimeter’s extensive OCT image library, which contains over two million breast tissue images.

Clinical Trial Results

Data presented at the American Society of Breast Surgeons (ASBrS) meeting demonstrated Claire’s effectiveness. A study of 206 patients showed that 17% had residual disease margins after standard of care (SOC) alone. However, when Claire was used in conjunction with SOC, it correctly detected residual disease in 40% of patients and cleared an additional 20% of patients from all residual disease, meeting a pre-specified performance goal (P = .0050). The overall accuracy of Claire was 88.1%.

In the trial, the signify total lumpectomy volume excised was 74 cm³, with Claire-aided shaves accounting for a small portion of the total volume removed (2.8 cm³ from 115 shaves). Twenty-six patients experienced a clinical benefit from the identification of residual disease by Claire after SOC was completed. Importantly, pathology confirmed that Claire identified disease missed by both standard of care and initial histopathology.

Addressing a Critical Need

“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden,” said Adrian Mendes, CEO of Perimeter Medical Imaging AI. “Claire’s FDA approval marks a major milestone in breast cancer care, as we advance our goal of reducing repeat surgeries so that no patient has to be told ‘we didn’t get it all.’”

Alastair Thompson, surgeon and professor at Baylor College of Medicine, added, “Intraoperative margin assessment remains one of the most pressing problems for both surgeons and their patients. The final results of this pivotal trial clearly demonstrate that the leverage of [Claire] has the potential to change the current paradigm by empowering surgeons to identify regions of interest, enhance real-time intraoperative decision-making, and reduce the incidence of re-excision due to unaddressed residual disease following lumpectomy.”

Future Developments

Perimeter Medical Imaging AI plans a nationwide launch of Claire in the coming weeks. The FDA has also authorized a pre-determined change control plan, allowing for AI enhancements to the device without requiring additional FDA approval or interaction, enabling continuous improvement based on data gathered from surgical procedures.

References:

• Perimeter Medical Imaging AI’s ‘Claire’ becomes first FDA-approved AI-enabled imaging device for breast cancer surgery. News release. Perimeter Medical Imaging. March 3, 2026. Accessed March 4, 2026. https://tinyurl.com/6ufu7ne7
• Detailed results from B-Series OCT with ImgAssist AI 2.0 pivotal trial presented at ASBrS 2025. News release. Perimeter Medical Imaging. May 5, 2025. Accessed March 4, 2026.