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Perimeter Medical Imaging AI

by Perimeter Medical Imaging AI · Based in Canada → — Transforming cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need.

Surgery

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Overview

Perimeter Medical Imaging AI offers medical imaging tools, notably the Perimeter S-Series Optical Coherence Tomography (OCT) system and the AI-enabled Claire™ system, designed to provide high-resolution, real-time visualization of excised tissue.

The technology is primarily intended for surgeons in oncology, particularly those performing breast-conserving surgeries. It is utilized in operating room settings to assist in intraoperative margin assessment of excised tissue specimens.

Within the clinical workflow, the Perimeter S-Series OCT system integrates as an adjunct to existing methods like specimen X-ray and pathology. The portable device allows for scanning of excised tissue specimens, providing cross-sectional images with 10 times higher resolution than standard X-ray and ultrasound at a 2mm imaging depth. Scan times are typically 1-2 minutes per margin, with an overall interpretation time of approximately 15 minutes. The tissue is preserved for pathology, and the device does not contact the patient or enter the sterile field.

Notable capabilities include:

Optical Coherence Tomography (OCT): Provides ultra-high-resolution, 3D images of tissue microstructures.
AI-Assisted Image Analysis: The Claire system, which received U.S. FDA premarket approval, combines proprietary AI with wide-field OCT imaging to highlight areas suspicious for breast cancer. This AI was trained on a proprietary image library of over 2 million breast tissue images.
Real-time Intraoperative Use: The system is designed to provide insights during surgery, allowing for immediate evaluation of excised tumor margins.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

Optical Coherence Tomography (OCT)
Real-time tissue imaging
Ultra-high resolution images
AI-powered image interpretation
Surgical margin assessment
Non-destructive imaging
Aids in identifying cancerous tissue

Use Cases

Intraoperative surgical margin assessment
Identification of cancerous tissue during surgery
Reducing re-excision rates in oncology
Enhancing surgical precision

What Physicians Need to Know

Evidence Base

Perimeter Medical Imaging AI's 'Claire' system utilizes Optical Coherence Tomography (OCT) and AI, trained on a proprietary library of over 2 million pathologically correlated breast tissue images. The technology provides high-resolution, 3D images of tissue up to 2mm below the surface, which is the clinically relevant margin width for breast cancer assessment. The AI highlights areas suspicious for cancer to guide surgeons. The S-Series OCT, a flagship product, provides real-time, cross-sectional margin visualization of excised tissue specimens at the cellular level. Perimeter's technology aims to improve the standard of care by providing real-time insights to reduce re-excisions and improve patient outcomes.

Clinical Validation Studies

Perimeter's Claire system received U.S. FDA premarket approval (PMA) as the first AI-enabled imaging device for intraoperative breast cancer margin assessment. It also received Breakthrough Device Designation from the FDA. A pivotal randomized controlled trial (RCT) for Claire (formerly Perimeter B-Series OCT with ImgAssist AI) 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. The primary endpoint of the trial was met, indicating a statistically significant reduction in patients with residual cancer during surgery. The AI algorithm accurately identified 96.8% of pathology-positive margins in Wide Field OCT images with high sensitivity and specificity. The company is actively building a strong body of clinical evidence, including published studies, papers, and RCTs. The clinical trial for Claire is registered as NCT05113927.

Alert Fatigue Management

While the provided information does not explicitly detail specific 'alert fatigue management' features for Perimeter Medical Imaging AI's tools, the system is designed to provide 'focused, actionable information in minutes' and the AI acts as a 'guide that points attention to areas worth a second look' to avoid overwhelming the surgeon. The AI overlays, which highlight suspicious microstructural features, can be toggled on, show less, or off, allowing for physician control over the level of AI guidance. This suggests an approach to integrate AI insights without creating excessive or irrelevant alerts, aligning with general strategies for managing alarm fatigue in healthcare by focusing on relevant and actionable notifications.

Differential Diagnosis Support

Perimeter Medical Imaging AI's 'Claire' system focuses on identifying focal areas suspicious for breast cancer within excised lumpectomy specimens. The AI is trained on millions of proprietary OCT images of cancerous and healthy breast tissue to highlight suspicious microstructural features associated with DCIS & IDC. While it provides detailed imaging and AI-powered detection of potential cancer, its primary function is not to offer a broad differential diagnosis for various conditions but rather to assist in the real-time assessment of surgical margins for breast cancer.

Guideline Update Frequency

A pre-determined change control plan (PCCP) was authorized as part of Claire's PMA approval, allowing for planned AI enhancements to be implemented without additional FDA interaction. This suggests a mechanism for continuous improvement and updates to the AI algorithm. Every surgical procedure performed with Claire generates new data that can be used to improve the AI product.

Clinical Workflow Integration

Perimeter's systems are designed to integrate seamlessly into the surgeon's existing workflow by providing focused, actionable information in minutes during surgery. The technology provides real-time insights in the operating room, allowing surgeons to make immediate decisions on margin status. The system does not impact specimen integrity or surgical and pathology workflows. The company offers on-site or remote clinical support for device deployment and operative workflow integration. The S-Series OCT system is available across the U.S. Claire is designed to bring additional information into the operating room during the window when the surgeon can still act, potentially reducing the need for re-operations.

Decision Audit Trail

While the provided information does not explicitly detail a 'decision audit trail' feature for Perimeter Medical Imaging AI's tools, the broader context of AI in healthcare emphasizes the importance of governance processes that can reconstruct how AI shaped care delivery, track model changes, and withstand audits. Healthcare organizations are advised to establish audit trails that preserve a chain of custody from AI generation through clinician review and ultimate adoption or rejection. Given Claire's FDA approval and Breakthrough Device Designation, it is likely that mechanisms for accountability and traceability of AI-assisted decisions are in place or being developed.

Physician Tip

Perimeter Medical Imaging AI's Claire system provides real-time, high-resolution 3D imaging of excised breast tissue margins with AI-powered detection of suspicious areas. This allows for immediate intraoperative assessment, potentially reducing re-excision rates in breast conservation surgery. The AI acts as an 'extra set of eyes' to guide your attention to areas that may be suspicious for cancer, but the ultimate clinical decision remains with you. The system integrates into existing surgical workflows, providing actionable insights in minutes without delaying the procedure. The AI overlays can be adjusted to your preference (on, show less, or off) to manage the level of guidance. This technology is intended to be used adjunctively with other standard methods for evaluating lumpectomy specimen margins and does not replace standard histopathology.

Perimeter Medical Imaging AI's 'Claire' system is designed for seamless integration into the intraoperative workflow during breast conservation surgery. The company provides on-site or remote clinical support for device deployment and operative workflow integration. The system's ability to provide real-time imaging and AI insights in the operating room means it can be incorporated without disrupting existing surgical and pathology workflows. Perimeter has also entered into systemwide agreements with healthcare providers like Intermountain Health to facilitate the deployment of their technology across multiple hospitals. The AI engine is continuously improved by data generated from every surgical procedure performed with Claire, indicating a closed-loop system for ongoing enhancement.

At a glance

Deployment On Premise (device In Operating Room)

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Details

Category	Clinical Decision Support & Reference, Pathology AI, Radiology & Imaging AI
Pricing	Unknown
Deployment	On-premise (device in operating room)
Mobile App	None
API Available	No
Languages	English
Training	Unknown
Target Size	Hospitals and cancer centers performing breast-conserving surgery.
Compliance
BAA Available	Unknown
HIPAA Compliant	Unknown
FDA Status	Cleared AI-estimated Perimeter Medical Imaging AI 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 company also has FDA 510(k) clearance for its S-Series OCT Imaging System as an imaging tool for evaluating excised human tissue microstructure. Claire™ received Breakthrough Device designation from the FDA.
Integrations
EHR	Not specified
Specialties	Surgery

Support & Reliability

Training Provided

Unknown

What the Web Says

Perimeter Medical Imaging AI's flagship product, Claire, is an FDA-approved, AI-enabled optical coherence tomography (OCT) imaging system designed to provide real-time insights into excised breast tissue during surgery. The goal is to help surgeons identify microscopic cancer at the margins and potentially reduce the need for repeat operations, which currently occur in 20-25% of breast cancer surgeries. The company has received positive attention from physicians and investors for its innovative approach to improving surgical outcomes and reducing healthcare costs.

Overall: Positive

Strengths

Provides ultra-high-resolution, real-time imaging of surgical margins, offering 10x higher resolution than X-ray and ultrasound.
AI-enabled system helps surgeons identify suspicious areas for cancer, streamlining review and potentially improving decision-making in the operating room.
Clinically validated to reduce residual cancer during surgery, with an 88.1% margin accuracy in trials.
Aims to reduce re-operation rates for breast cancer, leading to better patient outcomes and lower healthcare costs.
FDA-approved as the first AI-enabled imaging device for intraoperative breast cancer margin assessment.
Strong intellectual property with multiple patents and a proprietary dataset of over 2 million breast tissue images used for AI training.

Limitations

Reimbursement for the Claire device is still a hurdle, with the company awaiting a CMS decision on a new HCPCS code.
The company is burning cash and may require new funding.
Some employee reviews mention disorganization and poor leadership, with concerns about the product's potential failure.
Perimeter's OCT technology has not been evaluated by the FDA for use in any other tissue or health condition beyond breast cancer margin assessment.
Claire is an adjunctive tool and does not replace standard tissue histopathology assessment or diagnosis.
One Reddit user expressed difficulty in getting posts about the company approved on the platform, suggesting potential skepticism or moderation challenges.

Based on reviews from: G2, MedTech Spectrum, Perimeter Medical Imaging AI, Reddit, Citeline Insights, Dallas Innovates, AdvaMed, Microcap Opportunities, Indeed.com, MTEC, TIME, YouTube

Last updated: 2026-10-25

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Press & Coverage

PR Newswire

Perimeter Medical Imaging AI's 'Claire' Becomes First FDA-approved AI-Enabled Imaging Device for Breast Cancer Surgery

Perimeter Medical Imaging AI announced that its Claire™ system received U.S. FDA premarket approval, making it the first AI-enabled imaging device approved for intraoperative breast cancer margin assessment. This technology aims to help surgeons detect difficult-to-see cancer during breast-conserving surgery and potentially reduce re-operations.

2026-03

PR Newswire

Intermountain Health Brings Perimeter's Claire™ to the Operating Room, a Landmark in Breast Cancer Surgery Using AI

Intermountain Health has become the first health system in the U.S. to commercially deploy Perimeter's Claire OCT System™, an FDA-approved imaging device that uses AI during breast cancer surgery for real-time margin assessment. This deployment marks a significant step in utilizing AI to help surgeons visualize microscopic tissue structures.

2026-08

PR Newswire

Perimeter Medical Imaging AI Enters Systemwide Agreement with Intermountain Health

Perimeter Medical Imaging AI announced an agreement with Intermountain Health to deploy its S-Series OCT advanced imaging technology for tissue visualization in operating rooms. This agreement paves the way for broader adoption of Perimeter's intraoperative imaging technology across the Mountain West region.

2026-01

Canada Newswire

Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0

Perimeter Medical Imaging AI submitted a Premarket Approval (PMA) application to the U.S. FDA for its next-generation Perimeter B-Series OCT system, which combines AI technology with optical coherence tomography for use during breast-conserving surgeries. This submission is a major milestone for the company's AI-enabled wide-field OCT technology.

2025-03

Canada Newswire

Perimeter Medical Imaging AI Announces Alignment with FDA on Key Elements of Ongoing Clinical Trial Evaluating AI-enabled B-Series OCT Medical Imaging Technology

Perimeter Medical Imaging AI provided an update on its clinical trial for the B-Series OCT with ImgAssist AI, announcing alignment with the FDA on key elements including the introduction of an interim analysis. The company received approval to implement an enhanced AI algorithm in the trial.

2023-09

PMC (Life journal)

The Fusion of Wide Field Optical Coherence Tomography and AI: Advancing Breast Cancer Surgical Margin Visualization

This study explores the integration of Wide Field Optical Coherence Tomography (WF-OCT) with an AI-driven clinical decision support system to enhance breast cancer margin assessment. Results suggest the investigational deep learning model accurately identified 96.8% of pathology positive margins, highlighting the clinical viability of AI-enhanced margin visualization.

2023-12

AiThority

Perimeter Medical Imaging AI Announces Publication of New Clinical Evidence Featuring Case Studies from Commercial Use of Perimeter S-Series OCT

Perimeter Medical Imaging AI announced the publication of a new white paper featuring three case studies on the commercial use of its Perimeter S-Series OCT technology. The paper highlights how the ultra-high-resolution imaging tool provides real-time margin visualization during breast-conserving surgery.

2023-03

Proactive Investors (YouTube)

Perimeter Medical Imaging AI on FDA Clearance, AI-Assisted Surgery and 2026 Catalysts

Adrian Mendes, CEO of Perimeter Medical Imaging AI, discusses the company's technology for improving cancer surgery outcomes, recent milestones including FDA approval for Claire™, and upcoming growth catalysts for 2026 and beyond.

2026-06

Videos

Product demos, reviews, and walkthroughs for Perimeter Medical Imaging AI.

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Frequently Asked Questions

What is Perimeter Medical Imaging AI's 'Claire' system and how does it aid in clinical decision-making during breast cancer surgery?

Perimeter Medical Imaging AI's 'Claire' system is the first FDA-approved, AI-enabled imaging device for intraoperative breast cancer margin assessment. It uses optical coherence tomography (OCT) and AI to provide surgeons with real-time, high-resolution 3D images of excised breast tissue, highlighting areas suspicious for cancer to help them decide whether to remove more tissue before the patient leaves the operating room.

What are the regulatory and compliance statuses of Perimeter Medical Imaging AI's products?

Perimeter Medical Imaging AI's 'Claire' system received U.S. FDA premarket approval (PMA) in March 2026, making it the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. The technology also received Breakthrough Device designation from the FDA.

What are the alternatives to Perimeter Medical Imaging AI for intraoperative margin assessment in breast cancer surgery?

Traditional methods for intraoperative margin assessment include physical examination, specimen radiography, gross touch preparation, and in limited cases, intraoperative pathology. However, these methods often lack the resolution to identify microscopic residual disease at the margins.

What are the known limitations of Perimeter Medical Imaging AI's 'Claire' system?

The 'Claire' system is an adjunctive tool and is not intended to replace standard tissue histopathology assessment or be used for diagnosis. Its efficacy was evaluated after the completion of standard of care, and it has not been evaluated for use in other tissues or health conditions by the FDA. Additionally, it has limitations for concurrent use in surgeries with cryo-assisted localization and with specimen margins that are destroyed, damaged, or not intact prior to imaging.

How accurate and effective is Perimeter Medical Imaging AI's 'Claire' system in detecting positive margins?

The pivotal trial for '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. This suggests it can help surgeons more effectively address residual cancer at the surgical margin.

How does Perimeter Medical Imaging AI integrate with existing PACS and hospital workflows?

While specific details on PACS integration for 'Claire' are not extensively detailed, AI integration into PACS generally aims to enhance diagnostic accuracy and workflow efficiency by assisting in image analysis, automating routine tasks, and providing clinical decision support. Perimeter's goal is to integrate the technology into high-volume surgical centers.