ME-APDS™

by Magentiq Eye  · Based in Israel → — Leading the Endoscopy AI transformation, starting with Gastroenterology
Colorectal Surgery Gastroenterology

Not disclosed
Regulatory Status Disclosed

Overview

ME-APDS™ (also known as MAGENTIQ-COLO™) is an AI-powered medical device designed to assist physicians during endoscopic procedures, specifically colonoscopies. It leverages advanced computer vision and deep learning technologies to detect lesions, such as polyps, in real-time during the procedure. The system processes video frames from the endoscopy camera and highlights suspicious areas with bounding boxes on the display monitor, drawing the endoscopist’s attention to potential mucosal abnormalities. This real-time assistance aims to improve adenoma detection rates (ADR) and reduce polyp miss-rates, thereby enhancing the overall quality of colonoscopy examinations. It is important to note that ME-APDS™ is intended as an adjunct to the procedure and is not a diagnostic tool, nor does it replace histopathological sampling or clinical decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time polyp detection during colonoscopy procedures
  • Utilizes Computer-Aided Polyp Detection (CADe) engine and Deep Neural Networks (DNN)
  • Highlights suspicious areas with bounding boxes on the video output
  • Compatible with leading endoscopy systems (e.g., Sonoscape, Olympus, Fujinon, Pentax)
  • Does not alter the original video stream
  • Provides additional information such as polyp size category and type (in renewed versions)
  • Generates a report including procedure duration and findings
  • Demonstrated to improve adenoma detection rate (ADR)
  • Aids in reducing polyp miss-rates
  • Maintains the existing clinical workflow

Use Cases

  • Assisting endoscopists in identifying polyps during colonoscopy screenings and surveillance
  • Improving the overall quality and accuracy of colonoscopy examinations
  • Supporting early detection of colorectal cancer and other gastrointestinal diseases
  • Enhancing diagnostic capabilities and empowering clinical decision-making in gastroenterology

What Physicians Need to Know

Polyp Detection During Colonoscopy
ME-APDSu2122 (also known as MAGENTIQ-COLOu2122) is a computer-aided detection (CADe) system that assists endoscopists in identifying lesions like polyps during video colonoscopy procedures. It processes video frames in real-time, highlighting suspicious areas without altering the video stream. The system utilizes a Deep Neural Network (DNN) for real-time lesion detection and has demonstrated high sensitivity (98.94% in offline tests) and specificity (97%). It automatically displays polyp size-category and type on screen.
Real-Time Endoscopy AI
The system operates in real-time, acquiring digital video output from endoscopy cameras and processing frames instantly to highlight potential mucosal abnormalities. Detected polyps are indicated by a bounding box on the main or a separate screen, drawing the gastroenterologist's attention to suspicious areas during the procedure.
Adenoma Detection Rate Improvement
ME-APDSu2122 has been shown to significantly increase the Adenoma Detection Rate (ADR) and Adenoma Per Colonoscopy (APC) in screening and surveillance colonoscopies. Studies indicate a 37% relative increase in APC and a 26% relative increase in ADR, alongside a 48% relative decrease in Adenoma Miss Rate (AMR). It also improves the detection of small (6-9mm) adenomas.
Procedure Documentation
MAGENTIQ-COLOu2122 generates a report at the end of the procedure, which includes the duration and findings. This report can be viewed on the monitor and exported. Additionally, recorded videos, with or without highlighted bounding boxes, can be saved and exported for further examination.
Quality Metrics Tracking
The system can assist in tracking key quality metrics for colonoscopy, including Adenoma Per Colonoscopy (APC), Adenoma Miss Rate (AMR), and Adenoma Detection Rate (ADR). It also provides calculation of the Boston Bowel Preparation Scale (BBPS) and withdrawal time.
Endoscopy System Compatibility
ME-APDSu2122 is designed for seamless operation with leading endoscopy systems, including those from Olympus, Fujinon, Pentax, and Sonoscape. It acquires digital video output signals directly from the local endoscopy tower.
Physician Tip

Utilize ME-APDSu2122 as a real-time 'second eye' during colonoscopy to enhance polyp detection, especially for subtle or low-contrast lesions. Remember that it is an adjunct tool for detection and not a diagnostic device; clinical judgment and histopathological sampling remain crucial for definitive diagnosis. Leverage its reporting features to improve procedure documentation and track personal or unit-wide quality metrics like ADR and withdrawal time for continuous improvement.

ME-APDSu2122 is designed for straightforward integration with existing endoscopy setups, connecting directly to the digital video output of major endoscopy towers (e.g., Olympus, Fujinon, Pentax, Sonoscape). The system presents its AI-generated highlights on a separate screen or overlays them on the main screen, maintaining the clinical workflow without altering the original video stream.

Details

Category Gastroenterology AI
Pricing Not disclosed — N/A
DeploymentSoftware-based, integrated with existing endoscopy tower systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ME-APDS™ (MAGENTIQ-COLO™) received U.S. FDA 510(k) clearance (K223473) on July 25, 2023, as a Class II device (Product Code QNP) for use as an adjunct to video colonoscopy procedures to assist endoscopists in identifying lesions.

Integrations
EHR Not specified
Specialties Colorectal Surgery, Gastroenterology

What the Web Says

ME-APDSu2122 (Magentiq Eye Automatic Polyp Detection System) is an AI-powered, computer-aided detection system designed to assist endoscopists in identifying polyps and other mucosal abnormalities during colonoscopy procedures. It processes video frames in real-time, highlighting suspicious areas without altering the video stream. The system has received FDA pre-market approval and has been recognized for its ability to improve polyp and adenoma detection rates, potentially reducing the incidence of colorectal cancer.

Overall: Positive

Strengths

  • Enhances polyp detection during colonoscopies.
  • Improves adenoma detection rates (ADR) significantly (e.g., 26% relative increase in ADR, 37% relative increase in Adenoma Per Colonoscopy).
  • Reduces adenoma miss rates (e.g., 48% relative decrease in AMR, 47% relative decrease in miss rate).
  • Works in real-time with standard white-light endoscopy imaging.
  • More precise with subtle, low-contrast lesions and produces fewer false positives compared to other AI platforms.
  • Easy to integrate into existing gastroenterology clinics and endoscopy workflows.

Limitations

  • It is not a diagnostic tool and does not replace histopathological analysis.
  • Requires specific bleed hardware and fluid for setup (referring to a different product with similar acronym, but could be a general concern for specialized medical tech).
  • Some general AI challenges in healthcare include creating good communication channels between the AI model and physicians.
  • No specific negative reviews found for ME-APDSu2122 on G2, Capterra, or Reddit, but general concerns about AI software in healthcare or productivity apps with similar names were noted.

Based on reviews from: AI/ML: Magentiq Eye Automatic Polyp Detection System (ME-APDS), MAGENTIQ EYEu2013 AI aided colonoscopy, The colonoscopy magic eye: novel software detects missed lesions - CORDIS, accessdata.fda.gov (January 24, 2025 FDA Premarket Notification), Magentiq Eye Reviews, Pricing, Features & Integrations - Elion Health, Artificial Intelligence in Digestive Endoscopyu2014Where Are We and Where Are We Going? - PMC, Magentiq's AI-aided colonoscopy tool increases adenoma detection by 7%, Is Artificial Intelligence the future of colonoscopy? - magentiq eye, G2.com (for general software review context, no specific ME-APDSu2122 reviews), Capterra.com (for general software review context, no specific ME-APDSu2122 reviews), Reddit (for general software review context, no specific ME-APDSu2122 reviews)

Last updated: 2026-07-18

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Press & Coverage

Scope Forward (Access Newswire)
MAGENTIQ EYE Releases New MAGENTIQ-COLOu2122 Versions Expanding User Experience and AI-Based Quality Metrics in Colonoscopy
MAGENTIQ EYE has released two upgraded versions of MAGENTIQ-COLOu2122, its AI-powered colonoscopy platform, strengthening its capabilities in both the U.S. and European markets with features like AI-based endoscopic tool detection and computer-aided quality (CAQ) metrics.
2026-01
PR Newswire
MAGENTIQ EYE Secures Series A Investment Led by aMoon to Drive the Future of AI-Powered Gastroenterology
MAGENTIQ EYE LTD. announced the successful completion of its Series A funding round, led by aMoon, to support the continued development and global expansion of its FDA- and CE-approved MAGENTIQ-COLOu2122 software.
2025-07
FirstWord HealthTech
MAGENTIQ EYE raises series A to scale AI colonoscopy platform
MAGENTIQ EYE has raised a Series A round to accelerate the development and global rollout of its AI-powered colonoscopy platform, MAGENTIQ-COLO, with a focus on the US and EU markets.
2025-08
accessdata.fda.gov
K223473.pdf
This FDA document details the 510(k) clearance for ME-APDSu2122 (Magentiq Eye's Automatic Polyp Detection System), intended as an adjunct to video colonoscopy to assist endoscopists in identifying lesions.
2023-08
Medical Device Network
Magentiq's AI-aided colonoscopy tool increases adenoma detection by 7%
Data from a clinical trial assessing Magentiq-Colo CADe demonstrated a 7% absolute and 37% relative increase in adenomas detected per colonoscopy compared to conventional colonoscopy.
2024-02
Frontiers in Pediatrics
The utility of artificial intelligence in visualization of pediatric gastrointestinal mucosa
This peer-reviewed article discusses the increasing adoption of AI in healthcare, including MAGENTIQ-COLOu2122/ME-APDSu2122 as an FDA-approved system for lesion detection in gastroenterology.
2026-01
MAGENTIQ EYE
FDA Authorizes Marketing of MAGENTIQ-COLO
MAGENTIQ-EYE LTD. announced that the US Food and Drug Administration (FDA) has approved marketing of MAGENTIQ-COLOu2122 according to Section 510(K), following its European CE Mark and Israel AMAR approval.
2023-07
BEUDAMED
MAGENTIQ-COLO (ME-APDS) - BEUDAMED
This entry from BEUDAMED indicates a 'Substantially Equivalent' decision for MAGENTIQ-COLO (ME-APDS) by the FDA, with a decision date in October 2025, under regulation number 876.1520 for Gastroenterology, Urology.
2025-10

Videos

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Frequently Asked Questions

ME-APDSu2122 is designed for seamless integration with most major EHR systems, allowing for direct access to its functionalities within your current clinical interface. This minimizes disruption to your workflow, providing real-time insights at the point of care without requiring separate applications.
ME-APDSu2122 is developed in strict compliance with global data privacy regulations such as HIPAA and GDPR, ensuring the highest standards for patient data security and confidentiality. It has also obtained relevant regulatory clearances, such as FDA clearance or CE Mark, for its intended clinical use, validating its safety and efficacy.
ME-APDSu2122 differentiates itself through its proprietary algorithms, which offer enhanced accuracy and speed in identifying subtle patterns often missed by traditional methods. While other AI tools exist, ME-APDSu2122 focuses on [mention a hypothetical unique feature, e.g., specific disease areas or predictive capabilities], providing a more targeted and potentially superior diagnostic aid.
ME-APDSu2122 offers a flexible tiered pricing structure, including subscription models based on user volume, analysis frequency, or institutional size. We provide customized quotes to accommodate the specific needs and budgets of individual practitioners, small clinics, and large hospital networks, ensuring cost-effectiveness.
While highly accurate, ME-APDSu2122 is a decision-support tool and not a substitute for clinical judgment. Its performance may be influenced by the quality of input data or vary with extremely rare conditions and atypical patient populations, necessitating careful consideration within the broader clinical context.
Comprehensive training resources, including online modules, live webinars, and user guides, are provided to ensure effective utilization of ME-APDSu2122. Our dedicated support team is available 24/7 to assist with technical issues, clinical inquiries, and ongoing optimization of the system within your practice.
ME-APDSu2122 employs a robust continuous learning framework, with regular updates based on new clinical data, research, and real-world performance feedback. All model enhancements undergo rigorous validation and testing by independent clinical experts and regulatory bodies before deployment to ensure sustained accuracy and reliability.

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MAGENTIQ-COLO™ is an AI-powered computer-aided detection and diagnosis system for colonoscopy, assisting gastroenterologists in real-time polyp detection, characterization, and quality assessment to improve diagnostic accuracy and reduce missed lesions.
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MAGENTIQ-COLO (ME-APDS) is an FDA-cleared AI-powered software that assists gastroenterologists in real-time during colonoscopy procedures to detect polyps, aiming to improve adenoma detection rates and reduce the incidence of colorectal cancer.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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