FDA Awards Premarket Approval to AI-Enabled Imaging Device for Breast Cancer Surgery

Perimeter Medical Imaging AI Inc. has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for Claire (formerly the Perimeter OCT B-Series with ImgAssist AI 2.0), the first artificial intelligence (AI)-enabled imaging device authorized in the United States for intraoperative breast cancer margin assessment.

The technology received Breakthrough Device designation from the FDA and aims to enhance surgeons’ ability to detect difficult-to-see cancer during breast-conserving surgery and potentially reduce the need for re-operations.

“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden,” Perimeter Medical Imaging CEO Adrian Mendes stated. “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 so surgeons can rapidly adopt the industry’s first FDA-approved real-time AI-powered imaging technology for breast cancer surgery.”

Innovating the Standard of Care

Claire combines Perimeter’s proprietary AI with its patented wide-field OCT imaging to enable high-resolution, real-time evaluation of excised tumor margins. The system delivers 10 times higher resolution than standard X-ray and ultrasound at 2mm imaging depth—the clinically relevant margin width for breast cancer margin assessment. Claire’s AI technology was trained on Perimeter’s proprietary OCT photo library of more than 2 million breast tissue images.

Surgeons currently use a combination of physical examination and, in limited cases, intraoperative pathology to assess margins before sending specimens to pathology for final evaluation. As a result, patients may wait up to a week or more to learn whether margins are clear or additional surgery is required. Claire is designed to identify areas of concern during surgery, helping surgeons determine whether to remove more tissue before completing the procedure. National averages indicate repeat surgeries occur in about 20% of U.S. breast-conserving surgeries.¹

“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.”

Claire’s pivotal trial demonstrated an 88.1% margin accuracy and a statistically significant reduction in patients with residual cancer post-surgery compared to the standard of care alone. These results demonstrated super-superiority (lower bound of confidence interval for treatment effect greater than a predetermined minimal clinically meaningful difference) of its ability to help surgeons achieve clear surgical margins. This large-scale pivotal clinical trial was funded through a $7.4 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

A critical innovation behind Claire is its AI engine, trained on millions of proprietary OCT images of cancerous and healthy tissue. This image library is generated using Perimeter’s patented OCT imaging engine and is advantageous because every surgical procedure performed with Claire generates new data that can improve the AI product, helping to create better outcomes for future patients. Claire has been designed and developed on a diverse data set spanning numerous patient characteristics to help surgeons assess areas of interest during surgery. A pre-determined change control plan (PCCP) was authorized as part of the PMA approval and includes planned AI enhancements that can be implemented without additional FDA interaction.

“Developing AI for clinical use is incredibly challenging, requiring large, high-quality datasets that reflect real-life patient diversity,” Perimeter Medical Imaging Co-Founder/Chief Innovation Officer Andrew Berkeley remarked. “This approval reflects years of hard work with our clinical partners integrating AI directly into surgical decision-making and advancing its role from operational support to real-time patient care.”

Claire’s FDA approval positions Perimeter Medical Imaging at the forefront of AI-enabled intraoperative imaging and marks the first commercialization of its proprietary OCT-AI platform, according to company executives. Its patented wide-field OCT technology, proprietary dataset, and integrated AI capabilities target an estimated 300,000 annual U.S. breast cancer surgeries, while providing a scalable foundation for expansion into additional cancer indications over time.²

“I’ve been a major investor in Perimeter for several years, and it’s been the incredible clinical and commercial potential of Claire that has driven my excitement all along. After rigorous development, clinical and regulatory engagement, and collaboration with the medical community, I believe Perimeter is at the starting line of something truly transformational,” said Silicon Valley venture capitalist, entrepreneur, and former Facebook executive, Chamath Palihapitiya. “Claire delivers greater peace of mind. Both for the surgeon who currently faces nearly one-in-five odds of needing to perform repeat surgery due to positive margins, and for the breast cancer patient, who, under the current paradigm, typically has to wait (and worry) for up to 10 days to learn whether an additional surgery is required. A second surgery is an emotional and physical journey that we are trying to prevent. This is exactly the kind of AI-driven innovation that can improve the standard of care by delivering measurable, real-world medical impacts. I’m excited to see what Perimeter can accomplish, as it commercializes the first AI-enabled imaging device for breast cancer surgery.”

The Claire OCT System is an adjunctive three-dimensional imaging tool that provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm, which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed breast cancer diagnosis.

Based in Toronto, Canada, and Dallas, Texas, Perimeter Medical Imaging AI is a medical technology company developing ultra-high-resolution, real-time, advanced imaging tools to address unmet medical needs. Claire is a next-generation AI-enabled device.

Sources
¹ Kim Y, Ganduglia-Cazaban C, Tamirisa N, et al. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024;31:3649-3660
² American Cancer Society, Breast Cancer Facts & Figures, 2024-2025.