EW10-EC02 Endoscopy Support Program
Overview
FUJIFILM CAD EYE: EW10-EC02 Endoscopy Support Program
The FUJIFILM EW10-EC02 Endoscopy Support Program is a cutting-edge artificial intelligence (AI) powered software that forms a core component of the CAD EYE system. Designed to integrate seamlessly with FUJIFILM’s ELUXEO Endoscopic Imaging System, this program is a computer-assisted reading tool aimed at enhancing the real-time detection of colonic mucosal lesions, such as polyps and adenomas, during colonoscopy procedures.
Developed using advanced deep learning technology at Fujifilm’s global AI technology center in Tokyo, CAD EYE assists endoscopists in identifying difficult-to-spot lesions, including flat lesions, those located at the edge of the endoscopic view, or when multiple lesions are present in a single frame. Upon detection of a suspicious polyp, the system provides both visual alerts, such as a ‘Detection Box’ and a ‘Visual Assist Circle’ overlaid on the clinical images, and an auditory alert to notify the endoscopist. These alerts are user-adjustable to meet individual clinician preferences.
The EW10-EC02 Endoscopy Support Program can be utilized during both White Light Imaging (WLI) and Linked Color Imaging (LCI) modes, further enhancing visualization and detection capabilities. Studies have indicated that the use of CAD EYE can significantly improve adenoma per colonoscopy (APC) rates and adenoma detection rates (ADR), contributing to earlier detection and removal of pre-cancerous lesions.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered real-time detection of colonic mucosal lesions (polyps and adenomas)
- Utilizes deep learning technology for enhanced accuracy
- Seamless integration with FUJIFILM ELUXEO Endoscopic Imaging System
- Provides visual alerts (Detection Box, Visual Assist Circle) overlaid on clinical images
- Emits auditory alerts to notify endoscopists of suspicious findings
- Supports detection of difficult-to-spot lesions (flat, at edge of view, multiple lesions)
- Compatible with White Light Imaging (WLI) and Linked Color Imaging (LCI) modes
- User-adjustable alert preferences and controls via endoscope or processor
- Still image and movie recording with CAD EYE overlay functionality
- Network function for data transfer (FTP/FTPS/DICOM STORAGE, SAMBA STORAGE)
Use Cases
- Real-time detection of colonic polyps and adenomas during colonoscopy procedures
- Aiding endoscopists in identifying and removing pre-cancerous lesions
- Improving adenoma detection rates (ADR) and adenoma per colonoscopy (APC) rates
- Supporting screening and surveillance endoscopic mucosal evaluations
- Enhancing the efficiency and accuracy of endoscopic examinations
What Physicians Need to Know
To maximize the benefits of the EW10-EC02 Endoscopy Support Program (CAD EYE), physicians should actively utilize both White Light Imaging (WLI) and Linked Color Imaging (LCI) modes for comprehensive polyp detection. Pay close attention to the real-time visual (Detection Box, Visual Assist Circle) and auditory alerts, as these are designed to highlight subtle or easily missed lesions, including flat ones or those at the image periphery. Leverage the CAD EYE Characterisation function with BLI for immediate, AI-assisted differentiation between neoplastic and hyperplastic polyps to aid in real-time clinical decision-making. Familiarize yourself with the customizable alert settings and the ability to activate/deactivate CAD EYE via endoscope buttons or the processor for seamless integration into your workflow. Utilize the Full HD movie and still image recording capabilities for documentation, case review, and training purposes, but remember that these recorded files should not be used for primary diagnosis.
The EW10-EC02 Endoscopy Support Program (CAD EYE) is designed as a dedicated add-on to Fujifilm's ELUXEO Endoscopic Imaging System, requiring the EX-1 expansion unit for functionality. It seamlessly integrates with ELUXEO processors (e.g., VP-7000, EP-6000) and is compatible with 700 series colonoscopes. The system supports network functions for transferring still images (FTP/FTPS/DICOM storage) and movie files (SAMBA storage), indicating potential for integration with hospital Picture Archiving and Communication Systems (PACS) or other digital image management platforms for streamlined documentation and archiving.
Details
| Category | Gastroenterology AI |
| Pricing | Contact for pricing |
| Deployment | On-premise (integrated with existing endoscopy system hardware) |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated The EW10-EC02 Endoscopy Support Program received 510(k) clearance (K230751) from the U.S. FDA on December 15, 2023, as a computer-assisted reading tool to aid endoscopists in detecting colonic mucosal lesions in real time. |
| Integrations | |
| EHR | Not specified |
| Specialties | Colorectal Surgery, Gastroenterology |
What the Web Says
The Fujifilm EW10-EC02 Endoscopy Support Program, part of the CAD EYE system, is an AI-driven software designed to assist endoscopists in real-time detection and characterization of colonic polyps and adenomas during colonoscopy exams. It analyzes real-time endoscopic video images using deep learning algorithms, compatible with White Light Imaging (WLI) and Linked Color Imaging (LCI), to highlight potential lesions. The system aims to improve diagnostic accuracy and patient outcomes by enhancing the detection rate of precancerous lesions, including those that are flat, in corners of the view, or multiple lesions simultaneously.
Overall: PositiveStrengths
- Real-time AI-powered detection of polyps and adenomas.
- Aids in detecting challenging lesions (flat, in corners, multiple simultaneously).
- Can differentiate between hyperplastic and neoplastic polyps.
- User-friendly interface with visual and auditory alerts that don't interfere with the clinical image.
- Demonstrated improved adenoma per colonoscopy rates in clinical trials.
- Integrates with existing Fujifilm ELUXEO endoscopy systems.
Limitations
- Not intended to replace clinical judgment or decision-making.
- Potential for false positives or false negatives due to algorithm failure or user overreliance.
- Requires compatible Fujifilm hardware (EX-1 expansion unit and ELUXEO system).
- Limited information available from independent physician reviews or platforms like Reddit, G2, or Capterra.
- Availability may vary by country due to exclusive distribution arrangements.
- The software is not intended for the diagnosis, treatment, or prevention of diseases.
Based on reviews from: FDA Radiology AI Device - X-ray Interpreter, Moomoo, FUJIFILM | Radiology AI Companies - X-ray Interpreter, accessdata.fda.gov, CAD EYE | Fujifilm [United Arab Emirates], iF Design Award, Duomed, FDA, Medical Device Network, C.R Kennedy NZ, Case Study: CAD EYEu00ae by Fujifilm - AI-Enhanced Colonoscopy Detection and Diagnosis, REiLI-CAD-EYE-Factsheet.pdf, Fujifilm Receives 510(k) Clearance for CAD EYEu00ae, New AI-Powered Endoscopic Imaging Technology for Colonic Polyp Detection, SOFMEDICA.com, FUJIFILM Endoscopy, Fujifilm endoscopy: Pioneering Modern Endoscopy Imaging, Fujifilm Wins FDA Nod for AI-Powered Colonic Polyp Detection, AI Raises the Bar on Colonoscopy Performance with Fujifilm's CAD EYE, Becker's ASC, TechSci Research, PMC, PMC - NIH
Last updated: 2026-07-18
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate EW10-EC02 Endoscopy Support Program
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for EW10-EC02 Endoscopy Support Program.
Fujifilm wins FDA nod for AI-powered endoscopy tech that could rival
