Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has received from the US Food and Drug Administration (FDA) "a not substantially equivalent (NSE) letter regarding its 510(k) application to market PillCam Colon in the US." According to the FDA, an NSE letter means that the device was found to be not substantially equivalent to a legally marketed device, and may not be introduced into commercial distribution in the US.
Given Imaging president and CEO Homi Shamir said, "While we are disappointed by the FDA's decision we are evaluating our options to bring PillCam Colon to the US market as quickly as possible. We recently launched PillCam Colon in Europe and in other countries, and we are working closely with leading GI clinicians to determine its optimal role in patient care. On a parallel track and consistent with our commitment to innovation, we are accelerating development of a next generation colon capsule."
Given Imaging added that it did not expect this decision to have a material impact on 2008 revenue as PillCam Colon capsule sales in the US were not projected to be significant in 2008.
Given Imaging rose 1% in morning trading on the TASE after falling 13.8% yesterday. The company will publish its financial report for the fourth quarter of 2007 and the year as a whole, and also provide its guidance for 2008, tomorrow.
Published by Globes [online], Israel business news - www.globes-online.com - on February 19, 2008
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