Medscape September 26, 2022
Megan Brooks

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...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Physician, Provider, Technology
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