FDA Radiology AI Devices

CADDIE is a cloud-based AI software that helps gastroenterologists detect suspected colorectal polyps during colonoscopy procedures by analyzing live video from endoscopy. It highlights potential lesions with visual markers to aid clinical decision-making, improving polyp detection without replacing the physician's judgment.

The SKOUT system is a medical software device that uses artificial intelligence to assist gastroenterologists in real-time detection of potential colorectal polyps during colonoscopy procedures. It provides visual markers on the endoscopic video feed to highlight suspected polyps, helping doctors identify these abnormalities more effectively during colorectal cancer screening or surveillance.

The SKOUT system is a computer-aided detection software designed to assist gastroenterologists during colonoscopy by identifying potential colorectal polyps in real time. It highlights suspected polyps on endoscopic video to aid in colorectal cancer screening or surveillance, supporting clinicians in making more accurate evaluations.

The GI Genius system by Cosmo Artificial Intelligence is an AI-powered tool that helps doctors detect colonic mucosal lesions, such as polyps and adenomas, in real time during routine white-light endoscopy exams. It enhances lesion detection by analyzing live endoscopy video and highlighting areas of interest on the gastrointestinal tract on the display, supporting clinicians in making accurate diagnoses during colonoscopy procedures.

The EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.

ME-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.

The GI Genius System 100 and 200 are AI-powered computer-assisted detection tools used during colonoscopy to help doctors identify colonic lesions such as polyps and adenomas in real time. It integrates with standard white-light endoscopy video systems and highlights suspicious areas to support clinicians without replacing clinical judgment.

The SKOUT system is an AI-powered software tool that helps gastroenterologists detect potential colorectal polyps in real time during colonoscopy procedures. By providing visual markers on the colonoscopy video feed, it aids trained specialists in identifying polyps that might be missed, supporting better colorectal cancer screening and surveillance.

The SKOUT Software is an artificial intelligence (AI) based computer-aided detection tool designed to assist gastroenterologists during colonoscopies by identifying potential colorectal polyps in real time. It processes high-definition endoscopic video and highlights suspected polyps with visual markers on the video feed, helping clinicians detect polyps more effectively and support colorectal cancer screening and surveillance.

EndoScreener is a computer-assisted detection software that automatically identifies and highlights potential polyps during colonoscopy procedures. It processes the live video feed from the colonoscope and overlays blue boxes on suspected polyps, alerting the physician in real-time to improve polyp detection and assist clinical decision-making during colonoscopy in adults.