FDA Clears SKOUT, An AI-Assisted Polyp Detection Device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to SKOUT, a real-time computer-facilitated polyp detection device, aimed at assisting gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening.

Adenoma detection, as measured by adenomas per colonoscopy, is critical in estimating the incidence of colorectal cancer among adult patients. Evidence shows that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy.

In a multicenter, randomized, controlled clinical study, adults 40 years and older were randomly assigned to undergo standard colonoscopy with SKOUT (n=682) and only standard colonoscopy (n=677).

Results showed that the overall detection of adenomas per colonoscopy were higher with SKOUT than with only standard colonoscopy (719 detections with SKOUT vs 562 detections with standard colonoscopy). Furthermore, in proximal colon 5 to 9mm polyp detection, findings showed a 44% relative increase when using SKOUT vs 29% relative increase using colonoscopy. There was no decrease in total histology rates with SKOUT compared with standard colonoscopy.

—Priyam Vora

Reference:
Iterative Scopes receives FDA clearance for AI-assisted polyp detection device SKOUT. News release. Iterative Scopes. September 22, 2022. Date Accessed: October 05, 2022. https://www.businesswire.com/news/home/20220922005730/en/Iterative-Scopes-Receives-FDA-Clearance-for-AI-Assisted-Polyp-Detection-Device-SKOUT%E2%84%A2