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 25 May 2018

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News

FDA clears camera pill to photograph small intestine

The United States Food and Drug Administration today cleared for marketing a swallowable capsule containing a tiny camera that snaps pictures twice a second as it glides through the small intestine.

News image

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The product represents a technological advance in methods of examining the gastrointestinal tract.

The device, made by Given Imaging Ltd., an Israeli company with North American headquarters in Norcross, Ga., is intended to visualize the inside of the small intestine to detect polyps, cancer, or causes of bleeding and anemia.

Currently the standard method of detecting abnormalities is through endoscopic examination.

However, these scopes are unable to reach through all of the 20-foot-long small intestine, and thus provide only a partial view of that part of the gastrointestinal tract.

The camera pill can photograph parts of the small intestine that can't usually be reached with an endoscope.
FDA News
The camera capsule is designed to take photos of the entire small intestine, enabling doctors to see areas that the endoscope cannot reach.

The device, called the Given Diagnostic Imaging System, comes in capsule form and contains a camera, lights, transmitter, and batteries.

The capsule has a clear end that allows the camera to view the lining of the small intestine.

The patient swallows the capsule, and the natural muscular waves of the digestive tract propel it forward through the stomach, into the small intestine, through the large intestine, and then out in the stool.

The capsule transmits the images to a data recorder, which is worn on a belt around the patient's waist. The physician then transfers the stored data to a computer for processing and analysis.

The battery has an expected life of 8 hours, long enough to photograph the small intestine, but not long enough to photograph the entire gastrointestinal tract.

The United States Food and Drug Administration cleared the device based on both animal and clinical studies of safety and effectiveness conducted by the manufacturer.

In one of the human trials, Given Imaging studied the use of the camera capsule in patients with suspected small intestine disease. All patients had signs of either unexplained chronic gastrointestinal blood loss or anemia. All had undergone standard endoscopic and radiological evaluations prior to receiving the capsule.

Study results showed that the camera pill was safe, without any side-effects, and was able to detect abnormalities in the small intestine, including parts that cannot usually be reached by an endoscope.

The device is cleared for use alongside other endoscopic and radiological evaluations of the small bowel. The capsule was not studied in the large intestine.

FDA News
06 August 2001

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