🆕 The FDA has granted 510(k) marketing clearance to a new AI–assisted polyp detection device for use during colorectal cancer screening. FDAapproves GastroTwitter
The US Food and Drug Administration has granted 510 marketing clearance to a new artificial intelligence –assisted polyp detection device for use duringIn 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., 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.
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