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The FDA has recently approved the Given Diagnostic Imaging System, a tiny camera capsule that visualizes the inside of the small intestine to detect polyps, cancer or causes of bleeding and anemia.

At approximately 20 feet long, the small intestine is the longest part of the digestive tract and is situated between the stomach and the large intestine. Cancer of the small intestine is rare, accounting for only 1% to 2% of all gastrointestinal malignancies. Cancer of the small intestine resembles large bowel cancer in that it develops in the same way. Unfortunately, small intestine cancer is difficult to detect because screening procedures often cannot reach through all of the small intestine.

Currently, endoscopic examination is the standard method for detecting abnormalities in the intestines. During an endoscopic examination, doctors advance a scope down into the small intestine via the mouth. These scopes only provide a partial view of that portion of the bowel because they are unable to reach through the entire small intestine. The Given Diagnostic Imaging System is designed to take photos of the small intestine, thereby enabling doctors to see areas of the small intestine that the endoscope cannot reach.

The Given Diagnostic Imaging System is a capsule that contains a camera, lights, transmitter and batteries. The battery has an 8-hour life, which allows it to photograph the small intestine, but not the entire gastrointestinal tract. The capsule has a clear end that allows the camera to view the lining of the small intestine. After a patient swallows the camera capsule, it moves through the stomach, to the small intestine, to the large intestine and out in the stool. As the camera travels, it transmits images to a data recorder worn on a belt by the patient. Finally, the physician transfers the data to a computer for processing and analysis.

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FDA approval of the Given Diagnostic Imaging System was based on successful clinical studies that studied the effectiveness and safety of the device. All patients in the studies had suspected small intestine disease and had undergone standard endoscopic examinations prior to receiving the camera capsule. Study results indicated that the device was safe, caused no side effects and was able to detect abnormalities in the small intestine, including parts that cannot be reached by endoscope. The FDA approved the camera capsule for use along with, but not in place of, other endoscopic and radiological examinations of the small bowel. This procedure is available by prescription only.

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