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FDA Oks marketing of first AI device used to detect lesions during colonoscopy
The US Food and Drug Administration (FDA) recently approved the marketing of the GI Genius, a system that is uses artificial intelligence (AI) technology to aid in the detection of potentially cancerous polyps during a colonoscopy. During a colonoscopy, the technology highlights portions of interest of the colon and generates markers which are superimposed onto the video generated by the colonoscope camera in real time. These markers help to draw attention to areas of the colon that may require further assessment.
The FDA approval was based on findings from a multicenter, randomized controlled trial that was conducted in Italy and involved 700 participants between the ages of 40-80 years who were undergoing colonoscopy. A primary analysis of 263 patients found that colonoscopies that incorporated GI Genius technology identified precancerous and cancerous polyps in 55.1% of patients (polyps were later confirmed in the laboratory), compared to 42% of patients who underwent standard colonoscopy. The GI Genius did result in more biopsies being performed overall, though no additional adverse events were reported to be associated with the additional biopsies. There was also a slight increase in the number of suspected precancerous polyps that were biopsied and turned out not to be precancerous at all.
Overall, studies do show that even for well-trained clinicians, missed polyps remains a concern. With the FDA approval of the AI device, clinicians can now be equipped with a tool that can help to minimize the risk of missed colorectal polyps.
Take away message:
The FDA recently approved an artificial intelligence tool called the “GI Genius” that can be used during a colonoscopy to improve clinicians’ ability to detect precancerous and cancerous polyps.
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