FDA grants 510(k) clearance to AI-assisted polyp detection device

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 ofRead More