Perimeter Medical's Claire becomes first FDA-approved AI-enabled imaging device for breast cancer surgery

Perimeter Medical Imaging AI received U.S. Food and Drug Administration premarket approval for Claire. The device, formerly the Perimeter OCT B Series with ImgAssist AI 2.0, is the first AI enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. It received Breakthrough Device designation from the FDA. Claire combines proprietary AI with patented wide field OCT imaging technology. The system enables high resolution real time evaluation of excised tumor margins at 10 times the resolution of standard X ray and ultrasound at a 2 millimeter imaging depth. It was trained on the company's library of over 2 million breast tissue images. The pivotal trial demonstrated 88.1 percent margin accuracy. It also showed a statistically significant reduction in patients with residual cancer after surgery compared to the standard of care alone. Results from the trial supported by a US 7.4 million grant from the Cancer Prevention and Research Institute of Texas were presented at the 26th Annual Meeting of the American Society of Breast Surgeons. The company plans to begin a nationwide launch of the real time AI tool for margin assessment in the coming weeks. A predetermined change control plan was authorized as part of the approval to allow planned AI enhancements without further FDA interaction. The approval covers a platform that targets an estimated 300,000 annual U.S. breast cancer surgeries.