FDA Clears AI Colon Polyp Detector

FDA has cleared an Iterative Scopes 510(k) for SKOUT, a real-time computer-aided polyp detection device for adults undergoing colorectal cancer screening or surveillance. The device uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists, the company says. The clearance was based data from a multicenter clinical study that demonstrated it significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy, it says.

The device demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, “with an average of one additional adenoma resected for every 4.5 patients examined,” the company says. “Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall.”