The Food and Drug Administration (FDA) has approved a tiny camera patients can swallow to yield a living-color tour of the stomach and bowel. The medical diagnostic technology is a camera-in-a-capsule that takes pictures as it travels through the digestive tract. The device offers a less invasive, more patient-friendly technique for detecting abnormalities in the small intestine.
The camera-pill uses wireless technology to beam back color pictures as it painlessly wends its way through the digestive tract.
FDA Moved Fast
A study of 57 healthy people who swallowed the camera-pill found it safely passes through the digestive tract. In a study of 20 patients with intestinal abnormalities, the pill was found to be 60 percent effective in uncovering those abnormalities. By contrast, just 35 percent of abnormalities were diagnosed using the traditional method, a somewhat uncomfortable procedure where tubes fitted with tiny cameras, called endoscopes, are inserted down the throat to look at the small intestine.
In uncharacteristic fashion, the FDA allowed small studies of the camera-pill to go forward because the technology is similar to today’s endoscopic cameras, just in pill form instead of mounted on a tube. In an announcement approving the pill, the FDA stated it should be used in conjunction with traditional endoscopic tests, not as a stand-alone exam.
The camera-pill is disposable, excreted eight to 72 hours after being swallowed. Before it is expelled from the body, it will have beamed high-quality pictures to an external receiver the patient wears on a waistband.
Sci-Fi Health Care
Dr. Blair Lewis of New York’s Mount Sinai School of Medicine, in news reports by The Associated Press and Reuters, said, “It’s very sci-fi, and initially when the people from Given [Imaging Ltd., the firm that manufactures the camera-pill] approached me two years ago I didn’t believe it.”
Lewis has since tested the video pill on 20 patients and determined it works.
“I have been shown to be wrong—it is believable and shows tremendous promise,” Lewis said. He estimated that many of the nearly 25,000 people with internal bleeding of undiagnosed causes might be candidates to try the camera-pill.
The camera-pill can take pictures of the small intestine, a 20-foot-long “blind spot” for current diagnostic tools, said Dan Schultz, deputy director of the FDA office that reviewed the device. According to Schultz, the main advantage is in how the pill travels the entire length of the small intestine. Current technology is more limited, generally able to visualize only the upper part of the intestine.
A doctor administers the prescription-only camera-pill to the patient, who then goes about his day: Walking and activity are encouraged to help the pill move through the system. Twenty-four to 48 hours later, the doctor simply downloads into a computer the images from the receiver worn by the patient.
The camera-pill won’t replace colonoscopies, the exams that check for colon cancer, because its battery doesn’t last long enough to get to the large intestine. Nor can it be used for persons known or suspected to have intestinal obstructions, including problems called fistulas or strictures, because the pill might get stuck.
But patients with anemia and unexplained blood in their stool might be candidates for the camera-pill when a standard endoscopic exam can’t diagnose the problem.
The pill, called the M2A Swallowable Imaging Capsule, is made by Israel-based Given Imaging Ltd. An unidentified spokesperson for the firm said the capsules are available at a cost of $450 each. Doctors who wish to use the camera-pill in conjunction with their diagnostic exams will have to buy a $20,000 computer workstation.