Sweeping the length of the colon for the subtle signs of cancer can be a difficult task, with polyps hiding among a constantly shifting landscape of folds and shadows. But now the FDA has cleared its first artificial intelligence system for colonoscopy to illuminate lesions the human eye may miss.
The GI Genius, developed by Cosmo Pharmaceuticals and distributed internationally by Medtronic, is designed to be compatible with all agency-approved endoscopy video systems. On the physician’s feed, the add-on system highlights areas of interest, allowing for closer visual inspections, tissue biopsies or ablation, with the goal of finding cancers when they may be easier to treat.
“Studies show that during colorectal cancer screenings, missed lesions can be a problem even for well-trained clinicians,” Courtney Lias, Ph.D., the acting director of the FDA’s office for gastrointestinal, renal and general hospital devices, said in an agency statement.
In a clinical study of 263 participants being screened for colorectal cancer, researchers found the addition of the GI Genius system was able to identify more carcinomas and benign adenomas compared to standard colonoscopy alone, spotting lab-confirmed lesions in about 55% of patients versus 42%.
While use of the AI did lead to more biopsies being performed—including on lesions later found to not be adenomas—the study did not report additional perforations, infections or bleeding, according to the FDA.
The computer-aided detection system is not meant to replace lab analyses of retrieved tissue nor to help classify lesions or suggest a proper course of treatment, but to act as an automated second observer to help catch precancerous tissues and smaller, flatter polyps that may slip by unnoticed.
Following a two-year partnership, Medtronic and Cosmo hope the new de novo clearance from the FDA will help unlock a $1.1 billion market opportunity, with more than 19 million colonoscopies being performed in the U.S. each year and more than 1.8 million new colorectal cancer cases logged in 2018.
At the same time, the AI system may help improve and standardize physicians’ skills in the procedure. The GI Genius system has previously been available in Europe as well as in a limited number of markets across Asia, Australia and the Middle East.