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FDA Clears New AI Device to Aid Polyp Detection

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.

In the proximal colon, SKOUT showed a 44% relative increase in the detection of polyps measuring 5–9 mm; overall, it showed a 29% relative increase in the detection of polyps measuring 5–9 mm.

“Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients,” wrote study author Aasma Shaukat, MD, MPH, with NYU Grossman School of Medicine, in a company news release.

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.

The FDA has approved two other AI systems to aid polyp detection: EndoScreener (Wision AI Ltd) and GI Genius (Cosmo Pharmaceuticals NV).

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