Gastrointestinal technology developer Given Imaging has received U.S. Food and Drug Administration (FDA) clearance for its PillCam Colon capsule endoscopy product.
PillCam Colon may be used for detecting colon polyps in patients after an incomplete optical colonoscopy and if a complete evaluation of the colon is not technically possible, Given said. PillCam Colon received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.
PillCam Colon is currently available commercially in more than 80 markets, including Japan, Europe, Latin America, Canada, Australia, and parts of Asia and Africa, the company said.
