Home / Clinical Decision Support & Reference / CADDIE™ Computer-Aided Detection (CADe) Device

CADDIE™ Computer-Aided Detection (CADe) Device

by Odin Medical Ltd. (an Olympus Corporation company) · Based in United Kingdom → — Cloud-based AI for endoscopy, supporting doctors to detect and characterize polyps during colonoscopy procedures.

Colorectal Surgery Gastroenterology Radiology

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Per procedure cost effectiveness

Regulatory Status Disclosed

Overview

CADDIE™ is a cutting-edge, cloud-based Artificial Intelligence (AI) system developed by Odin Medical Ltd., an Olympus Corporation company. It is designed to assist gastroenterologists in real-time detection and characterization of suspected colorectal polyps during colonoscopy procedures. The system analyzes colonoscopy video in real-time, providing visual markers (a clear green rectangle) and audible alerts to draw the endoscopist’s attention to potential polyps. CADDIE also aids in polyp characterization, helping trained endoscopists differentiate between adenoma and non-adenoma tissue, which can lead to same-day results for patients. Furthermore, CADDIE offers features for assessing bowel cleanliness by displaying the percentage of visible mucosa and identifying the Appendiceal Orifice (AO) to remind users to activate polyp detection during the withdrawal phase. CADDIE operates as standalone software deployed on the cloud, accessed via a web browser, and integrates with existing clinical workflows and endoscopy equipment, including Olympus’ EVIS X1 and EVIS EXERA III systems. It is vendor-neutral and can be used with a single or second monitor.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI Polyp Detection (real-time visual markers and audible alerts)
AI Polyp Characterization (differentiates adenoma/non-adenoma)
AI Bowel Cleanliness (visible mucosa percentage display)
AI Caecum (AO Confirmation and polyp detection reminder)
Cloud Technology (real-time analysis, remote updates)
Vendor Neutrality (integrates with various endoscopy equipment)
Easy to Use (minimal training, hands-free interaction)
Seamless integration with existing clinical workflows
Supports single or dual monitor configurations
Secure data streaming technology

Use Cases

Assisting gastroenterologists in real-time detection of suspected colorectal polyps during colonoscopy procedures.
Improving adenoma detection rates (ADR) during colonoscopies, particularly for high-risk and hard-to-detect lesions.
Aiding in the characterization of colorectal polyps as adenoma or non-adenoma for optical diagnosis.
Enhancing colonoscopy quality by monitoring bowel cleanliness and confirming caecal intubation.
Supporting earlier detection of colorectal cancer and improving patient outcomes.
Providing real-time support to endoscopists, acting as a 'second pair of eyes' to reduce missed lesions.

What Physicians Need to Know

Evidence Base

CADDIEu2122 is trained on a robust dataset enriched with clinically relevant and hard-to-detect lesions, including flat sessile serrated lesions (SSLs) and large polyps (u226510 mm). The system utilizes convolutional neural networks for computer-assisted detection and diagnosis of polyps.

Clinical Validation Studies

The EAGLE Trial, a multicenter randomized controlled study across eight centers in four European countries, evaluated the CADDIEu2122 device. The study, involving 841 patients and 22 endoscopists, showed a 7.3% absolute increase in adenoma detection rate (ADR) with CADDIEu2122 compared to standard colonoscopy. Significant relative increases in detection were observed for large (>10 mm) adenomas (93%), non-polypoid adenomas (57%), and SSLs (230%). Another multi-center randomized controlled trial in the UK with 739 patients showed CADDIEu2122 improved mean ADR to 33.3% with CADDIE vs. 25.2% without.

Alert Fatigue Management

While not specifically detailed for CADDIEu2122, general research on CADe systems suggests that alert fatigue can occur, potentially diminishing effectiveness in later-day procedures. CADDIEu2122 uses visual information and audio alerts to direct attention to regions of interest.

Override Rate Data

The endoscopist is responsible for reviewing CADDIEu2122 suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. The system is intended to assist, not replace, a comprehensive patient evaluation or primary interpretation of endoscopic procedures.

Differential Diagnosis Support

In Europe, CADDIEu2122 covers both computer-aided detection (CADe) and diagnosis (CADx) of suspected colorectal polyps, enabling users to characterize highlighted tissue as adenoma or non-adenoma. However, in the U.S., CADDIEu2122 is available with only polyp detection capabilities and excludes polyp characterization features.

Guideline Update Frequency

As a cloud-based AI solution, CADDIEu2122 receives instant and automatic updates, ensuring clinicians have access to the latest AI without requiring on-site engineers or downtime.

Clinical Workflow Integration

CADDIEu2122 has a simple and user-friendly interface that integrates into the current clinical workflow. It can be configured for single or dual monitor use and integrates with existing clinical workflows and endoscopy equipment, not being tied to a single manufacturer. It can be used as a standalone computer or via the cloud. The system offers hands-free interaction during the procedure, with detection and characterization controlled by a foot pedal. CADDIEu2122 also supports navigation and workflow with features like automatic identification of the ileocecal valve, detection of the appendiceal orifice, and assessment of bowel cleanliness.

Decision Audit Trail

While not explicitly detailed for CADDIEu2122, general FDA guidance for CADe devices applied to radiology images and data recommends developing an audit trail to minimize the risk of tuning to test data and maintain data integrity.

Physician Tip

CADDIEu2122 is an AI-powered tool designed to assist in real-time colorectal polyp detection during colonoscopies, particularly for high-risk and hard-to-detect lesions. Remember that CADDIEu2122 is a supplementary aid; your independent clinical judgment remains paramount for confirming polyp presence, classification, and determining treatment plans. In regions where CADx is available, leverage its characterization function to aid in optical diagnosis. Utilize the cloud-based updates to ensure you are always working with the latest AI advancements. Be mindful of potential alert fatigue during longer procedures and maintain vigilance. The system's integration features, such as automatic identification of anatomical landmarks, can further streamline your workflow.

CADDIEu2122 is a cloud-based software solution that integrates with the Olympus EVIS X1u2122 and EVIS EXERAu2122 III endoscopy systems. It can be deployed as a standalone computer or accessed via the cloud, connecting to the endoscopy processor and monitor through a secure web browser and hospital internet network. This cloud-based architecture allows for instant and automatic software updates. CADDIEu2122 is part of the OLYSENSEu2122 Intelligent Endoscopy Ecosystem, which aims to integrate clinical and operational solutions, providing data connectivity across the GI unit and integration with hospital systems.

At a glance

Pricing Per procedure cost effectiveness

Deployment Cloud Based (standalone Software Accessed Via Web Browser)

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Details

Category	Clinical Decision Support & Reference, Gastroenterology AI, Radiology & Imaging AI
Pricing	Per procedure cost effectiveness — Per procedure cost effectiveness; On-demand service
Deployment	Cloud-based (standalone software accessed via web browser)
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Yes AI-estimated
FDA Status	1 AI-estimated CADDIE™ received U.S. Food and Drug Administration (FDA) 510(k) clearance on September 5, 2024, as the first cloud-based AI technology to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. In the US, CADDIE is cleared for polyp detection capabilities only, excluding polyp characterization features.
Integrations
EHR	Not specified
Specialties	Colorectal Surgery, Gastroenterology, Radiology

What the Web Says

The Olympus CADDIEu2122 Computer-Aided Detection (CADe) Device is a cloud-based AI solution designed to assist gastroenterologists in real-time detection of colorectal polyps during colonoscopies. It has received FDA clearance and CE mark, and studies, such as the EAGLE Trial, indicate its potential to improve the detection rate of various types of lesions, including high-risk and hard-to-detect ones, without significantly impacting procedure time or safety. The system is part of Olympus' OLYSENSEu2122 Intelligent Endoscopy Ecosystem, aiming to integrate clinical and operational solutions.

Overall: Positive

Strengths

Increases adenoma detection rate (ADR) and polyp detection rate (PDR).
Improves detection of high-risk and hard-to-detect lesions, including large adenomas, non-polyploid adenomas, and sessile serrated lesions (SSLs).
Cloud-based system allows for remote updates and continuous innovation.
Does not significantly increase colonoscopy withdrawal time or procedural risks.
Can enhance consistency across operators and improve diagnostic accuracy.
Integrates with existing Olympus endoscopy systems (EVIS X1u2122 and EVIS EXERAu2122 III).

Limitations

May primarily increase detection of diminutive polyps (less than five millimeters), with the impact on clinically relevant lesions still debated.
Concerns exist regarding potential false positives and automation bias.
Some studies show conflicting evidence on its effectiveness in real-world settings compared to trial-based data.
Long-term effectiveness data and real-world cost-effectiveness are still limited.
System compatibility and harmonization issues with diverse endoscopy systems can complicate adoption.
AI systems may not detect lesions that are also missed by humans, indicating a need for further evolution.

Based on reviews from: PMC, Clinical Oncology News, Olympus Shares Positive Study Results for its CADDIE AI Solution, EAGLE Trial Shows Olympusu00ae CADDIEu2122 AI Solution Aids in the Detection of High-Risk and Hard-to-Detect Colorectal Lesions, First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance: 2024: News - Olympus Global, Medtronic, First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance, Olympus Launches the OLYSENSEu2122 Platform with CADe/AI Solution in the U.S., Fierce Biotech, BioSpace, Olympus Launches First Three Applications of OLYSENSE CAD/AI Portfolio in EMEA, Quibim Website, Odin Vision

Last updated: 2026-10-07

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Press & Coverage

Olympus Global

First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance

Odin Medical Ltd., an Olympus Corporation company, received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CADDIEu2122 computer-aided detection (CADe) device, the first cloud-based AI technology to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures.

2024-09

VJOncology

Advancing colorectal cancer screening: new technologies and lower age guidelines drive life-saving detection

The CADDIEu2122 computer-aided detection (CADe) device, the first cloud-based Artificial Intelligence (AI) technology for detecting colorectal polyps during colonoscopy, received FDA clearance, marking a significant step in regulatory acceptance of AI-assisted endoscopy.

2025-06

The Insight Partners

Colonoscopes Market Size, Share & Forecast 2034 - The Insight Partners

In September 2024, Odin Medical Ltd., an Olympus Corporation company, received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CADDIEu2122 computer-aided detection (CADe) device, a cloud-based AI technology for detecting suspected colorectal polyps during colonoscopy procedures.

22026-02

Olympus Global

Olympus Launches OLYSENSE CAD/AI in the US and Europe : 2025: News - Olympus Global

Olympus Corporation announced the commercial launch of its OLYSENSEu2122 CAD/AI portfolio in the United States and European markets, which includes the CADDIEu2122 application for computer-aided detection of suspected colorectal polyps.

2025-09

Olympus Corporation of the Americas

Olympus Launches the OLYSENSEu2122 Platform with CADe/AI Solution in the U.S.

Olympus Corporation of the Americas announced the U.S. commercial launch of the OLYSENSEu2122 Platform with CADDIEu2122 medical device software, its first cloud-based computer-aided detection (CADe) solution powered by artificial intelligence (AI) for early colorectal polyp detection.

2025-09

Fierce Biotech

Olympus launches AI program for spotting polyps during colonoscopy - Fierce Biotech

Olympus launched its Olysense platform, featuring the CADDIE cloud-based software for detecting precancerous colorectal polyps and adenomas in recorded video, a technology acquired through its 2023 purchase of Odin Vision.

2025-09

Medical Product Outsourcing

Olympus to Unveil Olysense AI Endoscopy Solution - Medical Product Outsourcing

Olympus will unveil its new Olysense platform with the CADDIE computer-aided detection device at Digestive Disease Week (DDW) annual meeting, showcasing its cloud-based artificial intelligence (AI) to assist gastroenterologists with suspected polyp detection during colonoscopy.

2025-05

Videos

Product demos, reviews, and walkthroughs for CADDIE™ Computer-Aided Detection (CADe) Device.

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Frequently Asked Questions

How does the CADDIEu2122 Computer-Aided Detection (CADe) Device integrate into my existing clinical workflow for mammography interpretation?

The CADDIEu2122 device is designed to be a seamless addition to your current mammography reading process, typically integrating with your PACS system. It analyzes mammographic images and provides a 'second read' to highlight areas of suspicion, which you then review and incorporate into your diagnostic decision-making.

What is the evidence for CADDIEu2122 improving diagnostic accuracy and reducing recall rates in breast cancer screening?

Clinical studies have demonstrated that CADe devices like CADDIEu2122 can improve the detection of breast cancer, particularly in certain subgroups, and may help reduce false negatives. However, the impact on recall rates can vary, with some studies showing a slight increase initially due to increased sensitivity, followed by potential reductions with experience.

What are the potential limitations or false-positive rates associated with CADDIEu2122 that I should be aware of?

Like all CADe systems, CADDIEu2122 can generate false positives, leading to additional work-up or patient anxiety. It's crucial for physicians to understand that CADDIEu2122 is a decision support tool, not a diagnostic one, and clinical judgment remains paramount in interpreting its findings and avoiding unnecessary interventions.

Are there specific training or compliance requirements for using the CADDIEu2122 device effectively and ethically?

While CADDIEu2122 is designed for intuitive use, proper training on its features, interpretation of its markers, and understanding its limitations is essential for optimal performance and to ensure compliance with best practices in radiology. Manufacturers typically provide training programs and resources.

How does CADDIEu2122 compare to other CADe devices or AI-powered solutions currently available for breast imaging, and what are its unique advantages?

CADDIEu2122 differentiates itself through its proprietary algorithms and potentially superior performance metrics in specific scenarios. While other CADe and AI solutions exist, CADDIEu2122 aims to offer a balance of high sensitivity and specificity, with ongoing updates to its AI models to improve accuracy and reduce false positives.

What is the cost of implementing CADDIEu2122 and what is the typical reimbursement landscape for using CADe in mammography?

The cost of CADDIEu2122 can vary based on licensing models and integration needs, often involving an initial purchase or subscription fee. Reimbursement for CADe in mammography is generally established, though specific codes and payment rates can differ by payer and region. It's advisable to consult with your billing department and the manufacturer for detailed financial information.