Last month, the U.S. Food and Drug Administration (FDA) authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.
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. The GI Genius is designed to be compatible with many FDA-cleared standard video endoscopy systems.
The GI Genius module FDA approval marks a pivotal milestone for Cosmo Pharmaceuticals after more than 10 years of research and investments focused to generate disruptive innovations in the field of colon’s disease and optimization of the colonoscopy procedure. The development of GI Genius intelligent endoscopy module has been possible thanks to the leadership position of Cosmo, its unique proprietary library of high-definition loss-less videos of colonoscopies and its proprietary software and algorithms. The device is the first of its kind to obtain the FDA approval through the De Novo application. The device operates in real time to assist the endoscopist in the detection of lesions, is very simple to use and is compatible with all endoscopes.
Cosmo is the sole manufacturer. Medtronic is the exclusive world-wide distributor.
The FDA assessed the safety and effectiveness of the GI Genius through a multicenter, prospective, randomized, controlled study in Italy with 700 subjects 40-80 years old who were undergoing a colonoscopy for colorectal cancer screening, surveillance, positive results from a previous fecal immunochemical (fecal occult blood) test for blood in the stool or gastrointestinal symptoms of possible colorectal cancer. The primary analyses from the study were based on a sub-population of 263 patients who were being screened or surveilled every 3 years or more. Study subjects underwent either white light standard colonoscopy with the GI Genius (136 patients) or standard white light colonoscopy alone (127 patients).
According to the National Institutes of Health, colorectal cancer is the third leading cause of death from cancer in the US. Colorectal cancer usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). As part of a colorectal cancer screening and surveillance plan, clinicians perform colonoscopies to detect changes or abnormalities in the lining of the colon and rectum. A colonoscopy involves threading an endoscope (thin, flexible tube with a camera at the end), through the rectum and throughout the entire length of the colon, allowing a clinician to see signs of cancer or precancerous lesions.