Given Imaging Receives FDA Clearance for PillCam COLON
announced that the U.S. Food and Drug Administration has cleared PillCam COLON — a device that provides a new way to visualize the colon.
The device, an effective colon imaging option, may be used for detection of colon polyps in patients after an incomplete optical colonoscopy — without adequate preparation and an incomplete evaluation of the colon.
PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.
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