FDA Radiology AI Devices

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.

GI Genius is an artificial intelligence-based software device designed to assist endoscopists during colonoscopy. It analyzes live video images from standard white-light endoscopy in real time and highlights abnormal colonic mucosal lesions such as polyps and adenomas to aid detection. By providing visual markers on the video display, it helps clinicians identify lesions that might be missed, improving detection rates and supporting clinical decision making.