FDA approves PillCam Colon for Imaging-Given Imaging
The FDA has cleared PillCam Colon, from Given Imaging, as a new modality to provide Video visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible. PillCam Colon received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market. Given Imaging's PillCam SB3 was approved by the FDA in August 2013 for GI tract imaging.
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