Perimeter Medical Imaging AI Inc., a commercial-stage medical technology company, 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 AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. The technology received Breakthrough Device designation from the FDA and is designed 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,” 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.”
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 innovative AI technology was trained on Perimeter’s proprietary and growing OCT image library of over 2 million breast tissue images.
Today, surgeons 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. Today, national averages indicate repeat surgeries occur in about 20 percent of breast-conserving surgeries in the United States.1
The pivotal trial of Claire 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 aid surgeons in achieving clear surgical margins. This large-scale pivotal clinical trial would not have been possible without the generous grant of $7.4 million 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 can only be generated using Perimeter’s patented OCT imaging engine and represents a unique advantage, as every surgical procedure performed with Claire generates new data that can be used to improve the AI product, helping to create better outcomes for future patients. Claire has been designed and developed on a diverse data set spanning a multitude of patient characteristics to help surgeons assess areas of interest during surgery. This use of AI is what makes Claire one of the few AI-enabled class III devices on the U.S. market today. 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,” said Perimeter’s Chief Innovation Officer and co-founder, Andrew Berkeley. “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 at the forefront of AI-enabled intraoperative imaging and marks the first commercialization of its proprietary OCT-AI platform. The Company’s 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
Management believes this innovative, patented platform represents the initial step toward addressing a significantly larger global opportunity across additional cancer surgeries, biopsy procedures, and pathology applications.
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.
