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In that group, FDA reviewers report an adenoma detection rate of 55.1% with GI Genius against 42.0% with standard colonoscopy, and 0.81 adenomas per colonoscopy against 0.57. The program caused no added adverse events. FDA granted the De Novo request on 9 April 2021. The reviewers note that race was not recorded, that most patients were presumed to be white, and that only six endoscopists in Italy took part. They write that a reduction in cancer risk would need confirmation in further trials.","category":"general benefit","unexpected":false,"purpose":"GI Genius was built to help endoscopists detect colonic lesions such as polyps and adenomas in real time. 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De Novo classification request for GI Genius (DEN200055): decision summary. Granted 2021-04-09.","title":"De Novo classification request for GI Genius (DEN200055)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200055.pdf","date":"2021-04-09","written_by":"independent","quote":"The GI Genius procedures had an ADR* of 55.1% and the standard colonoscopy procedures had an ADR* of 42.0%."},{"kind":"peer-reviewed study","citation":"Repici A, Badalamenti M, Maselli R, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. 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