CAD EYE

by FUJIFILM Healthcare Americas Corporation  · Based in United States → — AI-powered precision for real-time colonoscopy polyp detection.
Colorectal Surgery Gastroenterology
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Regulatory Status Disclosed

Overview

CAD EYE is an advanced AI-powered endoscopic imaging system developed by FUJIFILM Healthcare Americas Corporation. It is designed to facilitate the real-time detection and characterization of colonic mucosal lesions, such as polyps and adenomas, during colonoscopy procedures. The system aids endoscopists in identifying and removing pre-cancerous lesions, regardless of their size, shape, or color. CAD EYE integrates AI image processing as an upgrade to Fujifilm’s ELUXEO Endoscopic Imaging System, utilizing deep learning technology developed at Fujifilm’s Tokyo AI center. It provides both visual and auditory alerts to physicians when a suspicious polyp is detected, seamlessly integrating into the existing workflow. Beyond detection, CAD EYE also offers characterization capabilities, assisting in the differentiation between hyperplastic and neoplastic polyps when used with Blue Light Imaging (BLI).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered real-time detection of colonic mucosal lesions (polyps and adenomas)
  • Supports detection of flat or peripheral lesions and multiple polyps simultaneously
  • Visual alerts (Detection Box, Visual Assist Circle) for suspicious polyps
  • Auditory alerts for suspicious polyps
  • Compatible with White Light Imaging (WLI) and Linked Color Imaging (LCI)
  • AI-powered characterization (neoplastic vs. hyperplastic) with Blue Light Imaging (BLI)
  • Seamless integration into physician's workflow
  • Can be activated/deactivated via endoscope button or processor
  • Records and stores full HD movies and still images (up to 30 hours of video)
  • Developed using deep learning technology

Use Cases

  • Improving adenoma detection rate during colonoscopy
  • Early detection of pre-cancerous colorectal lesions
  • Supporting endoscopists in identifying and removing polyps
  • Reducing missed lesions during colonoscopy
  • Assisting in the diagnosis of polyp histology (neoplastic/hyperplastic)
  • Enhancing the overall quality of colonoscopy procedures

What Physicians Need to Know

Polyp Detection During Colonoscopy
CAD EYE provides real-time detection of colonic mucosal lesions, including polyps and adenomas, using AI deep learning technology. It supports detection with both White Light Imaging (WLI) and Linked Colour Imaging (LCI). The system aims to improve the real-time polyp detection rate to an expert level by assisting in the recognition of flat lesions, multiple polyps simultaneously, and lesions located at the corners of the image. Visual alerts, such as a 'Detection Box' and 'Visual Assist Circle,' along with auditory alerts, notify the physician of suspicious polyps.
Real-Time Endoscopy AI
The tool supports real-time detection and characterization of polyps, processing up to 60 frames per second for immediate video analysis. It functions without requiring freezing or zooming of the endoscopic image during both standard and magnified observations. The visual cues provided by CAD EYE are overlaid on the clinical images in an unobtrusive manner, ensuring they do not interfere with the physician's existing workflow.
Adenoma Detection Rate Improvement
CAD EYE is designed to improve the adenoma detection rate (ADR) to an expert level. Clinical studies indicate that its use leads to significant advancements in colorectal cancer detection and diagnosis. It has been shown to detect considerably more adenomas during screening and surveillance compared to conventional high-definition colonoscopy without AI assistance, and without increasing procedure time. Studies have reported a 17% higher adenoma per colonoscopy (APC) with CAD EYE. It can also enhance the performance of endoscopists with lower baseline ADRs.
GI Pathology Analysis
The system supports the real-time characterization of polyps as either neoplastic or hyperplastic (non-neoplastic) when used in combination with Blue Light Imaging (BLI). This function aims to increase diagnostic accuracy to an expert level. CAD EYE visually indicates the characterization using different color codes within a 'Position Map' on the display. A pilot study demonstrated CAD EYE's ability to correctly characterize 94.8% of lesions during IBD surveillance.
IBD Assessment Tools
A pilot study has evaluated CAD EYE for the characterization of lesions in patients undergoing surveillance for Inflammatory Bowel Disease (IBD), demonstrating excellent accuracy, including for inflammatory pseudopolyps. While currently characterizing lesions as neoplastic or hyperplastic, future iterations could potentially offer classification based on specific subtypes (e.g., adenoma, sessile serrated lesion, inflammatory pseudopolyp, hyperplastic polyp) and provide a grade of dysplasia.
Procedure Documentation
CAD EYE facilitates procedure documentation by allowing full HD movies and still images, including the AI-generated results, to be recorded and stored. The compatible expansion unit EX-1 has an internal memory capable of storing up to 30 hours of video material. It supports Still Image Recording via FTP/FTPS/DICOM STORAGE and Movie Recording via SAMBA STORAGE.
Quality Metrics Tracking
While CAD EYE significantly contributes to improving key quality indicators like the Adenoma Detection Rate (ADR) by enhancing polyp and adenoma detection, the provided information does not explicitly detail built-in tools for direct 'tracking' of quality metrics within the CAD EYE system itself. The system's ability to record images and videos with AI findings can support retrospective quality assessment.
Endoscopy System Compatibility
CAD EYE is compatible with Fujifilm's ELUXEOu2122 endoscopy series, specifically the 700 and 800 series colonoscopes. It operates with a dedicated expansion unit (Fujifilm EX-1) and specific endoscopy support software (EW10-EC02 or EW10-EC01). The system can be easily activated or deactivated using a button on the endoscope handle or directly on the processor unit. It also supports the DICOM Standard to ensure compatibility and improve workflow efficiency with other imaging and information systems.
Physician Tip

To maximize the benefits of CAD EYE, physicians should actively utilize its real-time visual and auditory alerts to enhance the detection of subtle, flat, or multiple lesions, particularly in challenging anatomical areas. Leverage the characterization function with BLI to differentiate between neoplastic and hyperplastic polyps in real-time, which can aid in immediate decision-making regarding resection or surveillance. Customize alert volumes and assign preferred functions to the endoscope or processor switches for a personalized and comfortable workflow. While CAD EYE significantly improves ADR, maintaining continuous vigilance and adhering to established colonoscopy techniques remain crucial. Consider its utility in IBD surveillance for lesion characterization, acknowledging that further research is ongoing for broader applications in this specific patient population.

CAD EYE is designed as an integrated add-on module for Fujifilm's ELUXEOu2122 endoscopy series, requiring the Fujifilm EX-1 expansion unit and specific software (EW10-EC02 or EW10-EC01). It seamlessly integrates with the ELUXEOu2122 system's processor and compatible 700 and 800 series endoscopes. For documentation and archiving, the system supports DICOM for still image recording and FTP/FTPS/SAMBA for movie recording, facilitating integration with existing hospital IT infrastructure.

Details

Category Gastroenterology AI
Pricing Not specified — Not specified
DeploymentOn-premise (integrated with Fujifilm ELUXEO Endoscopic Imaging System)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FUJIFILM CAD EYE received FDA 510(k) clearance on March 20, 2024, for real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures. It consists of the Fujifilm EX-1 expansion unit and EW10-EC02 endoscopy support software.
Integrations
EHR Not specified
Specialties Colorectal Surgery, Gastroenterology

What the Web Says

CAD EYE is a colonoscopy AI detection system developed by Fujifilm, designed to assist endoscopists in identifying polyps and characterizing them in real-time. It utilizes deep learning to analyze endoscopic images, highlighting suspicious areas and providing immediate feedback on whether a detected lesion is likely neoplastic or non-neoplastic. Reviews suggest it is a valuable tool for improving adenoma detection rates and reducing inter-observer variability.

Overall: Positive

Strengths

  • Increases adenoma detection rate (ADR) by assisting in polyp identification.
  • Provides real-time characterization of polyps (neoplastic vs. non-neoplastic), potentially reducing unnecessary biopsies.
  • Reduces the miss rate for polyps, especially smaller or flat lesions.
  • User-friendly interface with visual cues (e.g., green frame for detection, purple frame for characterization).
  • May improve consistency across different endoscopists.
  • Non-invasive and integrated into the existing endoscopy workflow.

Limitations

  • Potential for false positives, leading to increased scrutiny of non-significant areas.
  • Requires a learning curve for endoscopists to fully trust and integrate the AI's suggestions.
  • Does not replace the need for thorough human inspection and decision-making.
  • Cost of implementation and integration into existing endoscopy systems.
  • Performance may vary based on image quality and specific colonoscopy conditions.
  • Limited data on long-term impact on patient outcomes and cost-effectiveness compared to traditional methods.

Based on reviews from: Fujifilm Healthcare, PubMed, Gastroenterology & Endoscopy News, Endoscopy International Open, Various medical journals and clinical studies, Healthcare IT News

Last updated: 2026-07-21

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Press & Coverage

Axis Imaging News
FDA OKs Fujifilm's CAD EYE for AI Colonic Polyp Detection
Fujifilm Healthcare Americas Corp. received U.S. FDA 510(k) clearance for CAD EYE, an AI detection system for endoscopic imaging that aids in the real-time detection of colonic mucosal lesions like polyps and adenomas during colonoscopy procedures. This system integrates AI image processing with Fujifilm's ELUXEO Endoscopic Imaging System and provides visual and auditory alerts for suspicious polyps.
2024-03
GlobeNewswire
Fujifilm Receives 510(k) Clearance for CAD EYEu00ae, New AI-Powered Endoscopic Imaging Technology for Colonic Polyp Detection
FUJIFILM Healthcare Americas Corporation announced 510(k) clearance for CAD EYE, its AI detection system for endoscopic imaging, designed to enable real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopies. The technology is clinically demonstrated to increase adenoma detection rates and will be commercially available in spring 2024.
2024-03
Medical Device Network
Fujifilm's endoscopic imaging system wins 510(k) clearance
Fujifilm Healthcare Americas has secured 510(k) clearance from the US FDA for its new AI-based endoscopic imaging detection system, CAD EYE, which works in real-time to improve the detection of colonic lesions like adenomas and polyps during colonoscopy procedures. Clinical studies indicate it can enhance colorectal cancer detection and diagnosis by identifying more adenomas.
2024-03
Fujifilm Healthcare Americas Corporation
Fujifilm Announces the Commercialization of Two Novel Endoscopic Imaging Technologies, CAD EYEu00ae and SCALE EYEu00ae at the Digestive Disease Week (DDWu00ae) 2024 Conference
FUJIFILM Healthcare Americas Corporation announced the commercialization of CAD EYE, its AI detection system for endoscopic imaging, and SCALE EYE, a novel imaging technology for measuring colonic lesions, both demonstrated at the 2024 Digestive Disease Week (DDWu00ae) conference. Since its 510(k) clearance in March, CAD EYE has been installed at five clinical sites in the U.S.
2024-05
Gastro Broadcast
Episode #57: Fujifilm's CAD EYE Enables Real-Time Detection of Polyps (and helps GI physicians prevent colorectal cancer) - Gastro Broadcast
Dr. Fred Rosenberg interviewed Anthony Borrelli, executive director of product & marketing for Fujifilm's endoscopy division, discussing the recent 510(k) clearance for CAD EYE. This AI detection system enables real-time detection of polyps and adenomas during colonoscopy procedures, specifically designed to support the detection of hard-to-miss lesions.
2024-04
FUJIFILM Healthcare Americas Corporation Blog
AI Raises the Bar on Colonoscopy Performance with Fujifilm's CAD EYE
This article highlights how Fujifilm's CAD EYE, launched in 2024, is improving colonoscopy performance by decreasing missed rates and increasing adenoma detection rates. Dr. Daniel von Renteln shared his team's clinical experiences, noting an 11% increase in ADR and a 30% relative risk reduction for patients at the University of Montreal Medical Center.
2026-01
Fujifilm India
FUJIFILM India installs Rajasthan's First CAD EYEu2122- AI Powered System for Endoscopy in Fortis Hospital Jaipur, pioneered by Dr. Shyam Sunder Sharma
FUJIFILM India announced the installation of Rajasthan's first CAD EYEu2122 AI-Powered System for Endoscopy at Fortis Hospital Jaipur, led by Dr. Shyam Sunder Sharma. This system aims to support early-stage detection of GI and colon cancers by analyzing endoscopic images for subtle abnormalities, boosting diagnostic accuracy and improving adenoma detection rates.
2025-10
pharmaphorum
NICE backs five AI tools for bowel cancer screening
NICE has recommended five AI tools, including Fujifilm's CAD EYE, for use in bowel cancer screening within the NHS over the next four years. These tools are intended to assist in identifying colorectal polyps that could become cancerous, with further evidence to be collected on their benefits in detection and characterization.
2025-11

Videos

Product demos, reviews, and walkthroughs for CAD EYE.

View all on YouTube

Frequently Asked Questions

CAD EYE is an AI-powered endoscopic imaging system designed to facilitate real-time detection and characterization of colonic mucosal lesions, such as polyps and adenomas, during colonoscopy procedures. It integrates seamlessly with Fujifilm's ELUXEO Endoscopic Imaging System, providing visual and auditory alerts to the physician when suspicious polyps are detected, without disrupting the existing workflow.
FUJIFILM Healthcare Americas has received U.S. Food and Drug Administration (FDA) 510(k) approval for CAD EYE. This clearance signifies that the system is deemed safe and effective for its intended use in aiding endoscopists in detecting and removing pre-cancerous lesions.
While CAD EYE significantly improves detection rates, some studies note limitations such as the potential for false-positive alerts, which could increase endoscopist workload. Additionally, its current characterization function primarily differentiates between neoplastic and hyperplastic lesions, and further research is needed for larger lesions and specific types like sessile serrated adenomas.
CAD EYE competes with other AI tools like GI Genius (Medtronic) and EndoBRAIN, offering both computer-aided detection (CADe) and diagnosis (CADx) functionalities on the same platform. Studies have shown comparable clinical outcomes between CAD EYE and GI Genius for optical diagnosis of small colorectal polyps, with CAD EYE demonstrating promising performance.
CAD EYE is typically offered as a capital equipment purchase, meaning healthcare facilities buy the system outright. The exact pricing is not publicly available and varies by region, system configuration, and additional services, often including software licensing, updates, and maintenance contracts.
CAD EYE utilizes AI deep learning technology trained with extensive clinical images, and it can store still images or movie files with CAD EYE results. While specific details on patient data handling within the system are not extensively detailed in the provided search results, Fujifilm generally adheres to privacy policies and information security standards for its healthcare solutions.
Clinical studies indicate that CAD EYE leads to a significantly higher adenoma detection rate (ADR) and adenoma per colonoscopy (APC) compared to conventional colonoscopy without AI assistance, without increasing procedure time. It has been shown to detect 17% more adenomas per colonoscopy and perform at a level comparable to an expert endoscopist and superior to a beginner.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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