The Food and Drug Administration (FDA) has cleared the GI Genius™ intelligent endoscopy module (Medtronic), an artificial intelligence (AI)-based system for use during colonoscopy.
The computer-aided detection system assists clinicians by identifying regions within the endoscope’s field of view where a colorectal polyp might be located. When a potential lesion is identified during colonoscopy, the device marks abnormalities (with a green square and short, low volume sound) and superimposes these markers on the video from the endoscope camera.
The approval of the device was based on data from a prospective, randomized trial in Italy that included 700 patients undergoing colonoscopy (ClinicalTrials.gov: NCT04079478). The aim of the study was to compare the additional diagnostic yield obtained by AI-aided colonoscopy to the yield obtained by the standard colonoscopy; the primary outcome was assessed in a subpopulation of 263 patients.
Patients were randomly assigned to undergo white light standard colonoscopy with the GI Genius (n=136) or standard white light colonoscopy alone (n=127). Results showed that the detection rate for adenomas or carcinomas was significantly higher with GI Genius (55.1% vs 42.0% with standard colonoscopy alone; observed difference: 13%). Findings also showed that use of the device led to more biopsies; however, there were no adverse events reported from these additional procedures. A small increase in the number of lesions biopsied that were not adenomas was observed.
“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,” 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.
While the GI Genius is able to provide an extended examination in real-time, it does not provide diagnostic assessment, nor does it suggest how to manage suspicious polyps.
The GI Genius module is compatible with any FDA-approved video endoscopy system.
1. FDA authorizes marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer. [press release]. Silver Spring, MD: US Food and Drug Administration; April 9, 2021.
2. US FDA grants de novo clearance for first and only artificial intelligence system for colonoscopy; Medtronic launches GI Genius™ Intelligent Endoscopy Module. [press release]. Dublin, Ireland: Medtronic PLC; April 12, 2021.