AI-Powered Imaging Brings Real-Time Margin Clarity to Breast Cancer Surgery

Repeat procedures due to residual disease create clinical and economic burdens; national data suggest that about 20% of breast-conserving surgeries in the United States require re-operation. Surgeons need real-time tools to detect difficult-to-see tumors at the point of care. A newly FDA-approved artificial intelligence (AI)-enabled imaging system now provides real-time assessment of excised margins during breast cancer surgery.

Perimeter Medical Imaging AI’s Claire (formerly the Perimeter OCT B‑Series with ImgAssist AI 2.0) has received U.S. Food and Drug Administration premarket approval (PMA) as the first AI-enabled imaging device in the United States indicated for intraoperative breast cancer margin assessment, following Breakthrough Device designation. The system is designed to enhance surgeons’ ability to identify areas of concern during breast‑conserving surgery and potentially reduce the need for re‑operations. Results supporting the approval were presented at the 26th Annual Meeting of the American Society of Breast Surgeons in 2025.

Claire integrates Perimeter’s proprietary AI with patented wide‑field optical coherence tomography (OCT) to deliver real‑time, volumetric, cross‑sectional depth visualization of excised tissue. The platform provides 10‑fold higher resolution than standard X‑ray and ultrasound at a 2 mm imaging depth, a margin width cited as clinically relevant for breast margin assessment. Its AI algorithm, trained on a proprietary OCT image library of more than two million breast tissue images, identifies and marks focal areas suspicious for cancer while the physician interprets images during surgery.

In a pivotal trial, Claire achieved 88.1% margin accuracy and produced a statistically significant reduction in patients with residual cancer after surgery compared with standard care alone. The study demonstrated “super‑superiority,” defined as a lower bound of the confidence interval for the treatment effect exceeding a predetermined minimal clinically meaningful difference. The trial was supported by a US$7.4 million grant from the Cancer Prevention and Research Institute of Texas.

“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden,” said Perimeter CEO, Adrian Mendes. "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.' We plan to begin a nationwide launch in the coming weeks so that surgeons can rapidly adopt the industry's first FDA-approved real-time AI-powered imaging technology for breast cancer surgery."

“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 Dr. Alastair Thompson, 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, and the Primary Principal Investigator of the pivotal trial that supported Claire's PMA application. “Claire has the potential to become a new standard in breast surgical care helping reduce re-excisions while improving patient outcomes.”

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