Shares of Israeli medical device maker Given Imaging Ltd fell more than 15 per cent as its application to market its capsule endoscope PillCam COLON did not receive clearance from US health regulators. Shares of Israeli medical device maker Given Imaging Ltd fell more than 15 per cent as its application to market its capsule endoscope PillCam COLON did not receive clearance from US health regulators.

On Monday the company said it received a not substantially equivalent (NSE) letter from the US Food and Drug Administration in response to its application for marketing the capsule endoscope.

PillCam COLON, a disposable miniature camera in a capsule that can be swallowed by patients, is used to detect disorders in the colon and is cleared for marketing in the European Union.

"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," said Given Imaging Chief Executive Homi Shamir.

The FDA letter is not expected to have any impact on 2008 revenue as PillCam COLON capsule sales in the US were not projected to be significant for the year, Given Imaging said in a statement.

Shares of the company were down $2.25 at $13.20 in morning trade on Nasdaq. They hit a 52-week low of $12.88 earlier in the session.