ME-APDS�; MAGENTIQ-COLO�
Magentiq Eye LTDME-APDS (Magentiq Eye’s Automatic Polyp Detection System) is an AI-powered software system that assists endoscopists during colonoscopy by automatically detecting and highlighting polyps and other mucosal abnormalities in real-time video images captured by standard white-light endoscopy. It runs on video output from standard colonoscopy equipment to enhance lesion detection, improving the accuracy and efficiency of colorectal screening and surveillance. It helps clinicians by providing visual prompts of suspected polyps, enabling timely clinical actions while functioning as an adjunct tool.
Intended Use
Intended to be used by endoscopists during video colonoscopy to assist identification of lesions such as polyps by highlighting regions with visual characteristics consistent with mucosal abnormalities. It is an adjunct to standard white-light endoscopy and not intended for diagnosis or to replace histopathological sampling.
Technology
The system acquires digital video output from an endoscopy camera, performs real-time processing using deep machine learning (deep neural networks) to detect regions consistent with polyps, and outputs annotated video indicating suspicious areas on a touchscreen and additional monitors. Major elements include a cart, computing device, touchscreen, and HDMI splitter with software for real-time AI detection of lesions in white-light endoscopy videos.
Performance
Performance was validated offline on 172 colonoscopy videos containing 449 polyps with excellent polyp-wise recall (up to 100% detection for small to large polyps). Clinical testing in a randomized multi-center trial with 950 patients showed that ME-APDS-assisted colonoscopy detected 37% more adenomas per colonoscopy than conventional colonoscopy, with no increase in adverse events or clinically relevant procedure delays. The system showed similar safety and effectiveness compared to the predicate GI Genius device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/17/2022
8 months - 2
FDA Approval
7/25/2023
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