Iterative Scopes’ Skout Receives 510(k) Clearance
Iterative Scopes has received 510(k) clearance from the FDA for its Skout device for detection of polyps in adults undergoing colorectal cancer screening or surveillance.
The device uses imaging technology that can recognize suspicious tissue and provide real-time feedback to gastroenterologists.
In clinical studies, Skout significantly improved adenoma detection in screening and surveillance colonoscopy compared with standard colonoscopy, the company said.
“Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes,” said Sloane Allebes Phillips, Iterative Scopes’ vice president of clinical operations.