FDA grants 510(k) clearance to AI-assisted polyp detection device
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The FDA granted 510(k) clearance to Iterative Scopes, in association with Provation, for its computer-aided polyp detection device for adults undergoing colorectal cancer screening, according to a press release.
The SKOUT device uses computer vision technology to identify suspicious tissue and provide real-time feedback to assist endoscopists in detecting potential colorectal polyps during colonoscopy procedures.
“Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes,” Sloane Allebes Phillips, vice president of clinical operations for Iterative Scopes, said in a press release. “We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency and ultimately change the standard of gastrointestinal care.”
The FDA based its clearance on data from a U.S.-based multicenter clinical trial for computer-aided polyp detection, in which SKOUT demonstrated a 27% relative increase in adenoma detection per colonoscopy with an average of one additional adenoma resected for every 4.5 patients examined. Further investigation showed SKOUT also demonstrated a 44% relative increase in 5 mm to 9 mm polyp detection in the proximal colon, as well as a 29% relative increase in 5 mm to 9 mm polyp detection overall.
“Knowing that patients can walk away from their appointment with the confidence that they received a high-quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” Aasma Shaukat, MD, MPH, professor of medicine and gastroenterology at NYU Grossman School of Medicine, said in the release. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.”