Toronto, Canada and Dallas, Texas, August 13, 2026
Perimeter Medical Imaging AI Inc. has announced that Intermountain Health has become the first U.S. health system to commercially deploy the company’s Claire OCT System™, an FDA-approved, AI-enabled imaging device designed to assist surgeons with breast cancer margin assessment during breast-conserving surgery. The deployment represents an important step in bringing artificial intelligence and real-time optical imaging into routine surgical practice. Claire is designed to provide surgeons with real-time visualization of microscopic tissue structures that may be difficult to identify with the naked eye, potentially providing additional information while surgery is still underway.
AI Imaging Supports Real-Time Cancer Margin Assessment
Breast-conserving surgery presents a significant clinical challenge: surgeons must remove cancerous tissue while preserving as much healthy tissue as possible. Removing too little tissue can leave undetected cancer behind and may require another operation, while removing excessive tissue can affect cosmetic outcomes. Claire is designed to address this challenge by combining optical coherence tomography (OCT) imaging with an artificial intelligence computer-aided detection algorithm that identifies and marks areas suspicious for breast cancer in excised tissue. The technology provides three-dimensional, real-time depth visualization and is intended to support physicians during evaluation of lumpectomy margins. The system builds on Perimeter’s S-Series OCT platform, which uses optical coherence tomography, a light-based imaging technology capable of providing cellular-level tissue visualization. Claire analyzes images generated during surgery and uses AI to highlight areas that may warrant additional attention from the surgical team. The technology is intended to function as an adjunct to standard clinical assessment rather than replace established pathology methods.
Intermountain Health Begins Commercial Deployment
Intermountain Health’s deployment marks the transition of Claire from clinical development into commercial clinical practice. The system is currently deployed at LDS Hospital and American Fork Hospital under a systemwide agreement between Intermountain Health and Perimeter. The health system said the technology provides surgical teams with additional information at the point of care, when it may have the greatest opportunity to influence decisions during a procedure. The company highlighted the potential importance of real-time margin assessment because a substantial proportion of breast-conserving surgery patients may require additional surgery when cancer is not detected in the operating room during the initial procedure. By providing another source of information during surgery, Claire is intended to help physicians identify potentially suspicious tissue while the patient remains in the operating room.
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FDA-Approved AI Device Moves Into Clinical Care
Claire’s commercial deployment is notable because it represents the use of an FDA-approved AI-enabled imaging device inside the operating room for breast cancer surgery. The system is indicated as an adjunctive imaging tool for patients with a biopsy-confirmed diagnosis of breast cancer undergoing evaluation of margins from excised lumpectomy tissue. Its intended use includes physician interpretation of the images alongside other standard methods. Importantly, Claire is not intended to replace standard tissue histopathology or serve as a standalone diagnostic tool. The device also has specific patient and procedural limitations described in its labeling. These include restrictions involving age, sex, metastatic disease, certain breast cancer characteristics, pregnancy, lactation, previous ipsilateral breast surgery, and other clinical circumstances.
The commercial introduction of Claire highlights the growing integration of AI, advanced imaging, and real-time decision-support technologies in cancer surgery. For breast-conserving procedures, access to additional intraoperative information could support more informed surgical decisions and potentially help address the challenge of repeat procedures. Intermountain Health’s adoption also provides an early example of how an FDA-approved AI medical device can move from clinical evidence into everyday healthcare delivery. As deployment expands, continued clinical experience and evaluation will help determine the technology’s role in improving surgical workflows and breast cancer care.
Source: Perimeter Medical Imaging AI press release
