Given starts small US study of next-generation PillCam Colon
This article was originally published in Clinica
Executive Summary
Given Imaging has started a 50-patient US trial of its PillCam Colon 2 video capsule to confirm procedures and logistics. The company plans to use this information in a larger trial that, if positive, will support its 510(k) application to the US FDA, for colorectal cancer screening in patients unwilling to undergo standard colonoscopy. The Yoqneam, Israel-based firm launched the next-generation device in Europe in November 2009 after CE marking it in September (www.clinica.co.uk, 23 November 2009). Given now plans to expand its European sales efforts for the product, and will also launch it in Canada and several Latin American countries. PillCam Colon 2 provides “superior imaging” over the original PillCam Colon device, Given claims. Neither device is currently approved in the US.
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