The U.S. Food and Drug Administration (FDA) authorized marketing of the GI Genius, which the agency says is 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 FDA granted marketing authorization of the GI Genius to Cosmo Artificial Intelligence, Ltd.
In a separate release, Medtronic said it is the exclusive worldwide distributor of the GI Genius module. In addition to the United States, the GI Genius module is available in Europe and select markets in Asia, Australia, and the Middle East.
“Artificial intelligence has the potential to transform healthcare to better assist healthcare providers and improve patient care. When AI is combined with traditional screenings or surveillance methods, it could help find problems early on, when they may be easier to treat,” said Courtney H. Lias, PhD, Acting Director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office in the FDA’s Center for Devices and Radiological Health. “Studies show that during colorectal cancer screenings, missed lesions can be a problem even for well-trained clinicians. With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise.”
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 FDA assessed the safety and effectiveness of the GI Genius through a 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).
The primary endpoint of the study compared how often colonoscopy plus GI Genius identified a patient with at least one lab-confirmed adenoma (precancerous tumor) or carcinoma (cancerous tumor) to how often standard colonoscopy made the same identifications.
In the study, colonoscopy plus GI Genius was able to identify lab-confirmed adenomas or carcinomas in 55.1% of patients compared to identifying them in 42.0% of patients with standard colonoscopy, an observed difference of 13%.
While use of this device led to more biopsies being performed, there were no adverse events reported with the additional biopsies, such as perforations, infections, or bleeding. However, there was a slight increase in the number of lesions biopsied that were not adenomas.
The FDA reviewed the GI Genius through the De Novo premarket review pathway, a regulatory pathway 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.
