Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) announced that it has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for Claire™, an AI-enabled imaging system designed for intraoperative breast cancer margin assessment. The approval marks the first time an artificial intelligence-powered imaging device has been cleared in the United States for real-time use during breast-conserving surgery.
Previously known as the Perimeter OCT B-Series with ImgAssist AI 2.0, Claire™ also received the FDA’s Breakthrough Device designation. The system is intended to help surgeons detect cancerous tissue that may be difficult to identify during surgery, with the goal of reducing repeat procedures caused by residual disease.
Addressing a Persistent Surgical Challenge
Repeat breast cancer surgeries remain a significant clinical and economic burden. National data indicate that approximately 20 percent of patients undergoing breast-conserving surgery in the United States require additional operations due to positive margins.
“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden,” said Adrian Mendes, Chief Executive Officer of Perimeter. He described the FDA approval as a major milestone and said the company plans to begin a nationwide commercial launch in the coming weeks, enabling broader adoption of what it calls the industry’s first FDA-approved, real-time AI-powered imaging technology for breast cancer surgery.
Currently, surgeons rely primarily on physical examination and, in some cases, limited intraoperative pathology to evaluate margins before specimens are sent for final pathology review. Patients may wait up to a week or longer to learn whether additional surgery is required. Claire™ is designed to identify areas of concern during the initial operation, allowing surgeons to remove additional tissue immediately if needed.
Advanced Imaging and AI Integration
Claire™ combines Perimeter’s proprietary artificial intelligence with patented wide-field optical coherence tomography (OCT) imaging. The system provides high-resolution, real-time visualization of excised tumor margins at a depth of 2 millimeters, which is considered the clinically relevant margin width for breast cancer assessment. According to the company, the device delivers 10 times the resolution of standard X-ray and ultrasound imaging at that depth.
The AI engine behind Claire™ was trained on a proprietary library of more than two million OCT images of breast tissue. Each procedure performed using the system contributes additional imaging data, which can be used to further refine the AI model over time.
The FDA’s PMA approval includes authorization of a pre-determined change control plan (PCCP), allowing for certain planned AI enhancements to be implemented without additional FDA interaction. Perimeter noted that Claire™ is among a limited number of AI-enabled Class III medical devices currently available in the U.S. market.
Clinical Trial Results Show Statistically Significant Improvement
Claire™’s approval was supported by results from a large-scale pivotal clinical trial. The study demonstrated an 88.1 percent margin accuracy rate and showed a statistically significant reduction in patients with residual cancer following surgery compared with standard care alone.
Findings were presented at the 26th Annual Meeting of the American Society of Breast Surgeons. According to the company, the trial met criteria for “super-superiority,” meaning the lower bound of the confidence interval for treatment effect exceeded a pre-defined threshold for clinical significance.
The trial was supported in part by a $7.4 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
“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, Section Chief of Breast Surgery at Baylor College of Medicine and primary principal investigator of the pivotal trial. He said the technology has the potential to reduce re-excisions while improving patient outcomes.
Platform Expansion and Market Opportunity
Perimeter estimates that approximately 300,000 breast cancer surgeries are performed annually in the United States, representing the initial target market for Claire™. The company said its proprietary OCT-AI platform could also be expanded over time to support additional cancer surgeries, biopsy procedures, and pathology applications.
Management described the FDA approval as the first step toward addressing a broader global opportunity in intraoperative imaging and cancer care.
Chamath Palihapitiya, a Silicon Valley venture capitalist and longtime investor in Perimeter, said he believes the company is positioned at the beginning of a potentially transformative shift in surgical imaging. He emphasized the emotional and physical toll associated with repeat surgeries and said technologies that can reduce that risk may offer meaningful benefits to both surgeons and patients.
With FDA approval secured, Perimeter is preparing for commercial rollout, positioning Claire™ as a new AI-driven tool aimed at improving surgical precision and reducing the likelihood of repeat breast cancer operations.
