FDA Radiology AI Devices

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.

GI Genius is an AI-powered software and hardware system that helps doctors detect precancerous lesions like polyps in the colon during colonoscopy procedures in real-time. It enhances standard white-light endoscopy video by highlighting suspected lesions with superimposed green boxes, improving detection rates and potentially reducing colorectal cancer risk.