Japan's PMDA Approves PillCam Colon For Diagnosis Of Colonic Disease
Japan's Pharmaceuticals & Medical Devices Agency (PMDA) has cleared Given Imaging's PillCam colon for the diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy. Homi Shamir, President and CEO of Given Imaging, stated that meaningful sales of PillCam colon capsule will commence immediately in the country after obtaining reimbursement.
Reimbursement in Japan is expected to become effective during the H1 2014, subject to government discretion. PillCam colon received the CE mark approval in September 2009 and is commercially available throughout 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 US and certain other countries.
The PillCam colon video capsule is equipped with two miniature colour video cameras (one on each end), a battery and an LED light source; it measures 11 x 31mm. The device is designed to be ingested by the patient and transmit up to 35 frames per second for approximately ten hours to a recording device worn by the patient. Data is transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.