FDA Okays Marketing Of First Device Using AI To Help Detect Colon Cancer Early On

GI Genius, developed by Cosmo Artificial Intelligence, Ltd., has become the first device that uses artificial intelligence or AI to help detect potential signs of colon cancer to get U.S. Food and Drug Administration's marketing approval.

The new device uses AI based on machine learning to assist clinicians in detecting potential irregularities or lesions, such as polyps or suspected tumors, in the colon in real time during a colonoscopy.

Colorectal cancer is the third leading cause of death from cancer in the United States, according to the National Institutes of Health. Such cancer usually starts from polyps or other precancerous growths in the rectum or the colon, and clinicians usually perform colonoscopies to detect changes or abnormalities in the lining of the colon and rectum.

In a statement, the FDA noted that 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 AI algorithm techniques to identify regions of interest. The GI Genius is designed to be compatible with many FDA-cleared standard video endoscopy systems.

The FDA's decision on GI Genius' safety and effectiveness was based on a multicenter, randomized, controlled study in Italy with 700 subjects 40-80 years old who were undergoing a colonoscopy for colorectal cancer screening.

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 percent of patients compared to identifying them in 42.0 percent of patients with standard colonoscopy, an observed difference of 13 percent.

The FDA added that the device is not intended to characterize or classify a lesion, nor to replace lab sampling as a means of diagnosis. GI Genius only identifies regions of the colon within the endoscope's field of view where a colorectal polyp might be located, allowing for a more extended examination in real time during colonoscopy.

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