Given pounces on new FDASIA provisions for "faster" direct de novo COLON 2 application
This article was originally published in Clinica
Executive Summary
Given Imaging has seized the direct de novo pathway now available under the FDA Safety and Innovation Act (FDASIA) to apply for market approval of its PillCam COLON 2 capsule endoscopy system for visualisation of the lower gastrointestinal tract. The Yoqneam, Israel firm believes that the pathway introduced by the new guidelines (www.clinica.co.uk, 14 September 2012) may expedite the regulatory approval process “by a few months”. The objective of the COLON 2 is to “improve the standard of care for patients who are currently unable to undergo an exam, while minimising potential adverse events, and reducing the risks associated with radiation-based alternative procedures, such as CT colonography or double-contrast barium enema”.