FDA Clears New AI Device to Aid Polyp Detection

[MITHU]

The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance to a new artificial intelligence (AI)–assisted polyp detection device for use during colorectal cancer screening. In a clinical trial, the detection rate of adenomas by endoscopists who used the device, which is called SKOUT, was 27% higher in comparison with the rate for endoscopists who worked without computer assistance. Endoscopists using SKOUT (Iterative Scopes, Inc) detected 1.05 adenomas per colonoscopy, vs 0.83 for those who did not use the device, a statistically significant difference.

[Aletti]

@mithu When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it, and it tracks the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the endoscopist's view during polyp removal.