The FDA has sent Given Imaging, a subsidiary of Elron and RDC, a not substantially equivalent (NSE) letter regarding its 510(k) application to market PillCam Colon in the United States.
According to the FDA, a NSE letter means that the device was found to be not substantially equivalent to a legally marketed device, and may not be introduced into U.S. commercial distribution.
"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,” said Homi Shamir, Given Imaging’s president and CEO.
The Tel Aviv, Israel-based Given Imaging said that it does not expect the decision to have a material impact on 2008 revenues, as PillCam Colon capsule sales in the United States were not projected to be significant in 2008.