Nov. 7, 2003 — Given Imaging Ltd., an Israel-based maker of integrated camera-in-a-pill technology, has received clearance from the U.S. Food and Drug Administration for use in children, according to a company news release.
The clearance, for children ages 10-18, was based on a 30-patient study at Sainte-Justine Hospital in Montreal. It concluded that capsule endoscopy diagnosed or definitively excluded a bleeding source, small bowel polyps or Crohn’s disease in 29 of 30 patients studied with no major side effects, the release said.
Given Imaging makes the Given Diagnostic System featuring the M2A Capsule Endoscope, a noninvasive method for direct visualization of the entire small intestine. It received FDA approval for use in adults in 2001.