Timothy Ritter, MD, Senior Medical Director, Department of Research and Education GI Alliance Research speaks about U.S. FDA Grants De Novo Clearance for First and Only Artificial Intelligence System for Colonoscopy; Medtronic Launches GI Geniusâ„¢ Intelligent Endoscopy Module.
In the United States, the Food and Drug Administration (FDA) approved de novo clearance for the GI GeniusTM intelligent endoscopy module. The GI Genius module is the first and only commercially viable artificial intelligence (AI)-based computer-aided detection (CADe) method for detecting colorectal polyps. The module, which works with every colonoscope video, gives doctors a new tool to combat colorectal cancer, which is the third most prevalent cancer worldwide, with 1.8 million new cases in 2018.
The GI Genius module employs sophisticated artificial intelligence to highlight the location of precancerous lesions in real time with a visual marker, acting as a constant second observer. It uses sophisticated algorithms to analyze photographs and spot and mark anomalies that are associated with polyps, like tiny flat polyps that may otherwise go undetected by the naked eye. According to studies, having a second observer will improve polyp detection rates and reduce the chance of colorectal cancer by 3% with every 1% rise in adenoma detection rate (ADR). 3,2 As compared to colonoscopy alone, the GI Genius module has seen a 14 percent absolute improvement in ADR for both flat (42 percent increase) and polyploid (36 percent increase) lesions, improving precision and reducing the risk of interval cancers between colonoscopies.
Cosmo Pharmaceuticals invented and manufactures the GI Genius module, which Medtronic is the sole worldwide distributor. On April 9, 2021, the FDA granted de novo clearance to the GI Genius intelligent endoscopy module. The GI Genius module is distributed in Europe, as well as select markets in Asia, Australia, and the Middle East, in addition to the United States.
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Link to updated video 2022: https://oncologytube.com/video/41293/gi-genius-vs-standard-colonoscopy-is-it-better?channelName=Hackensack