The U.S. Food and Drug Administration authorized the marketing of artificial intelligence (AI) software to assist gastroenterologists in the detection of lesions (such as polyps or suspected tumors) in the colon in real-time during endoscopic colonoscopies.
The FDA reviewed this AI software application through an expedited pathway rather than the traditional 510(k) process. The de novo premarket regulatory pathway used by the FDA for this AI application is available for some low-to-moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.
The GI Genius is composed of hardware and software designed to highlight portions of the colon where the device detects a potential lesion. The software uses artificial intelligence algorithm techniques to identify regions of interest. During a colonoscopy, the GI Genius system generates markers, which look like green squares and are accompanied by a short, low-volume sound, and superimposes them on the video from the endoscope camera when it identifies a potential lesion. These signs signal to the clinician that further assessment may be needed, such as a closer visual inspection, tissue sampling, testing or removal, or ablation of (burning) the lesion.