Given Imaging submits PillCam Colon 2 application to FDA Given Imaging announced that it has filed a FDA application seeking regulatory clearance to market its PillCam Colon 2 for visualization of the lower gastrointestinal tract. Based on guidance provided by the FDA, 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.
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