For immediate release:

The U.S. Food and Drug Administration has approved the marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning, to help clinicians detect lesions (such as polyps or suspected tumors) in the colon in real time. to detect during a colonoscopy.

‘Artificial intelligence has the potential to transform healthcare to better assist healthcare providers and improve patient care. When AI is combined with traditional screening or supervision methods, it can help detect problems early on, when they are easier to treat, ”said Courtney H. Lias, Ph.D. acting director of the GastroRenal, ObGyn, office of general hospitals and urology in the FDA’s center for devices and radiological health. “Studies show that missed lesions during approval of colorectal cancer can be a problem even for well-trained clinicians. With the FDA’s approval of this device, clinicians now have a tool that can improve their ability to detect gastrointestinal lesions that they would otherwise have missed. ”

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer death in the United States. Colorectal cancer usually begins with polyps or other pre-cancerous growths in the rectum or colon (colon). As part of a plan for the examination and observation of colorectal cancer, clinicians perform colonoscopies to detect changes or abnormalities in the lining of the colon and rectum. A colonoscopy involves stringing an endoscope (thin, flexible tube with a camera at the end), through the rectum and over the entire length of the colon, so that a clinician can see signs of cancer or lesions.

The GI Genius consists of hardware and software designed to highlight portions of the colon where the device detects a possible lesion. The software uses artificial intelligence algorithm to identify regions of interest. During a colonoscopy, the GI Genius system generates markers that look like green squares and are accompanied by a short, low volume sound, and place them on the video from the endoscope camera when it identifies a possible lesion. These signs indicate to the clinician that further assessment may be necessary, such as a closer inspection, tissue sampling, testing or removal, or ablation of (burning) of the lesion. The GI Genius is designed to be compatible with many FDA-cleared standard video endoscopy systems.

The FDA assessed the safety and efficacy of the GI Genius through a multicenter, prospective, randomized, controlled trial in Italy with 700 subjects aged 40-80 years who underwent a colonoscopy for colorectal cancer surveillance. , positive results from a previous fecal immunochemistry. (fecal occult blood) test for blood in the stool or gastrointestinal symptoms of possible colorectal cancer. The primary analyzes of the study were based on a subpopulation of 263 patients who were screened or examined every 3 years or more. 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 frequently colonoscopy plus GI Genius identified a patient with at least one laboratory-confirmed adenoma (precancerous tumor) or carcinoma (cancerous tumor) with how often standard colonoscopy made the same identifications. In the study, colonoscopy plus GI Genius was able to identify laboratory-confirmed adenomas or carcinomas in 55.1% of patients compared with their identification in 42.0% of patients with standard colonoscopy, an observed difference of 13%.

While the use of this device has resulted in more biopsies being performed, no adverse events have been reported with the additional biopsies, such as perforations, infections or bleeding. However, there was a slight increase in the number of lesions that were not adenomas.

The GI Genius is not intended to characterize or classify a lesion, nor to replace laboratory samples as a diagnosis. The device does not provide a diagnostic assessment of pathologists in colorectal polyps, nor does it suggest to the clinician how to treat suspicious polyps. GI Genius only identifies regions of the colon within the field of view of the endoscope where a colorectal polyp may be present, allowing a more extensive examination in real time during colonoscopy. The clinician must decide whether the identified region does contain a suspected lesion, and how the lesion should be managed according to standard clinical practice and guidelines.

The FDA has reviewed the GI Genius through the De Novo Review Route, a regulatory route for some low to moderate risk devices that is new and for which there is no legal predicate device on which the device can claim significant equivalence.

The FDA’s Device and Radiological Health’s Digital Health Center of Excellence looks at the future of AI-based technology, including its action plan for artificial intelligence and machine learning (AI / ML) as a medical device (SaMD).

The FDA has granted marketing authorization for the GI Genius to Cosmo Artificial Intelligence, Ltd.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.