PillCam Colon passes EU
This article was originally published in The Gray Sheet
Executive Summary
Given Imaging announces CE mark for the PillCam Colon Oct. 20. The firm plans to launch the ingestible video capsule following completion of more clinical trials underway in the U.S. and Europe. A three-center, 91-patient Israeli study showed that PillCam Colon identified 76% of polyps compared with 80% by colonoscopy, the current gold standard. Given anticipates filing for FDA clearance by year-end (1"The Gray Sheet" Nov. 14, 2005, p. 14). The firm's PillCam SB for the small intestine and PillCam ESO for the esophagus already are available in the U.S...