Given Imaging files with FDA to market Pillcam Colon 2

Given Imaging originally intended the the PillCam Colon 2 capsule to replace colonoscopies, but it is now indicated as complementing them.

Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has applied to the US Food and Drug Administration (FDA) for approval to market the PillCam Colon 2 endoscopic capsule for visualization of the lower gastrointestinal tract.

Given Imaging has submitted its PillCam Colon 2 application through a direct de novo pathway. Under new guidelines specified by the FDA Safety and Innovation Act of 2012, the company believes that the direct de novo pathway may expedite the regulatory approval process by a few months.

Given Imaging originally intended the the PillCam Colon 2 capsule to replace colonoscopies, but it is now indicated as complementing them. The narrower indication reduces the target market for the product from $4 billion to $1.7 billion.

Published by Globes [online], Israel business news - www.globes-online.com - on November 27, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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