Given Imaging's PillCam COLON Cleared In Japan By PMDA - Quick Facts

(RTTNews) - Given Imaging Ltd. (GIVN) reported that PillCam COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency or PMDA for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.

Commenting on the clearance, Homi Shamir, President and CEO, Given Imaging, said: "The decision could expand our potential customer base in Japan from approximately 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over 1,000,000 potential patients."

After a physician identifies blood in a patient's feces, only 54.7% of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons, Given Imaging added.

Subject to government discretion, reimbursement in Japan is likely to become effective in the first half of 2014. PillCam COLON received the CE Mark in September 2009 and is commercially available across Europe, Latin America, Canada, and parts of Asia. PillCam COLON is pending FDA clearance and is not cleared for marketing or available for commercial distribution in the U.S. and certain other countries.