Video-capsule endoscopy developer Given Imaging has received regulatory clearance to sell its PillCam Colon product in Japan.
PillCam Colon was cleared by the country's Pharmaceuticals and Medical Devices Agency (PMDA) for diagnosing colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.
This clearance has the potential to expand Given's activities in Japan from approximately 1,000 physicians to potentially 10,000, and it could have a major effect on adherence to screening guidelines for more than 1 million potential patients, according to the company.
