FDA approves Claire AI intraoperative imaging system for breast cancer

Perimeter Medical Imaging AI announced March 3, 2026 that the U.S. Food and Drug Administration granted Premarket Approval to Claire™, the company’s optical coherence tomography imaging system enhanced with proprietary artificial intelligence. The Toronto- and Dallas-based firm described Claire as the first U.S. AI-enabled intraoperative imaging device for breast cancer and said the approval follows a year-long regulatory push and a pivotal trial intended to support a PMA filing.

Perimeter previously filed a PMA on March 17, 2025 for a next-generation B-Series OCT system with ImgAssist AI 2.0, and company materials say that pivotal trial “easily met its primary endpoint.” The trial received support from a Cancer Prevention and Research Institute of Texas grant of up to US$7.4 million, the company said. Perimeter also markets an FDA-cleared S-Series OCT system that it calls available across the U.S.

Company executives framed the approval as a potential shift in how surgeons assess margins during breast-conserving surgery. Adrian Mendes, Perimeter’s chief executive officer, said at the time of the PMA submission: “The FDA PMA submission is a major milestone – our first regulatory approval application for our AI-enabled wide-field OCT technology, as well as for a specific indication label.” Mendes and company materials have highlighted industry context, noting surgeons historically face “nearly 1-in-5 odds” of needing to perform repeat surgery because of positive margins and that patients can wait up to seven days for post-operative pathology reports.

Perimeter’s vice president for clinical and medical affairs, Dr. Sarah Butler, said the pivotal trial results were encouraging and suggested the technology could reduce re-excision rates. “The trial easily met its primary endpoint, demonstrating that intraoperative margin assessment using OCT combined with Perimeter’s AI technology may be able to help lower re-excision rates by identifying regions of interest and guiding real-time decisions by surgeons on margin status in the OR,” Butler said.

Regulatory records show the company has prior FDA device activity. A Special 510(k) for an OTIS 2.1 OCT system was reviewed in 2021, with the agency finding the device substantially equivalent and permitting marketing under general controls. The new PMA is a higher bar intended for devices that pose greater risk or represent novel technology.

Perimeter’s announcement did not explicitly state whether Claire is the commercial name for the B-Series OCT with ImgAssist AI 2.0 that the company submitted in 2025; company materials treat Claire and the B-Series as closely related but stop short of a definitive one-to-one identification. Perimeter also has not published full pivotal-trial statistics or the complete Summary of Safety and Effectiveness Data in the company excerpts provided.

For surgeons and patients, the company argues the device could shorten waiting times for margin assessment and reduce the emotional and physical burden of repeat surgeries. Hospitals and health systems will now be watching for the device’s labeled indication, post-approval data, and reimbursement pathways as Perimeter moves from regulatory clearance toward commercialization.