Given Imaging is already redefining the way gastrointestinal diagnosis is carried out. For GI physicians in clinics and hospitals, Given Imaging technology is now being recognized as the gold standard in detecting disease of the small intestine, resulting in more accurate diagnosis of a range of gastrointestinal disorders. For patients, Given Imaging’s PillCam™ Capsule Endoscope offers the first effective, patient friendly gastrointestinal endoscope on the market, that is now reimbursed for most of the U.S. reimbursed population. For the healthcare system and third party payers worldwide, Given Imaging offers a first-line, cost-effective, ambulatory diagnostic procedure that can save precious resources.
Given Imaging’s flagship technology is the Given Diagnostic System, featuring the PillCam™ Capsule Endoscope. It is currently marketed in the United States and in 60 other countries for visualizing the small intestine and has benefited tens of thousands of patients worldwide.
The company plans to leverage its technology as a diagnostic platform for other areas of the gastrointestinal tract including the esophagus, the stomach and the colon. A new PillCam™ Capsule Endoscope for esophageal examination is currently in clinical trials.
The system received clearance from the FDA in August 2001 as an adjunctive tool for visualizing abnormalities of the small intestine and received permission to affix the CE mark in May 2001.
The removal of the “adjunctive tool” qualifier in July, 2003 is consistent with the recent publication by Rex et al (AJG, June 2003) that shows PillCam™ Capsule Endoscopy as the new gold standard for diagnosing diseases of the small bowel.