The U.S. Food and Drug Administration has cleared Yoqneam, Israel-based Given Imaging's PillCam COLON for use for patients after an incomplete optical colonoscopy, according to a Given Imaging news release.
The PillCam COLON is an ingestible capsule containing a miniature camera that transmits four or 35 frames per second for 10 hours as it travels through the digestive system.
The news release notes approximately 750,000 patients in the U.S. undergo an incomplete colonoscopy every year, which adds costs, inconvenience and risks of additional procedures required to complete the exam.
"Among the limited alternatives available after incomplete colonoscopy, PillCam COLON gives us a minimally invasive, radiation-free option that provides endoscopic images of the same basic type that have made colonoscopy so useful," said Douglas Rex, MD, distinguished professor of medicine and chancellor's professor at Indiana University School of Medicine and director of endoscopy at Indiana University Hospital in Indianapolis, in the news release.
Dr. Rex was the PillCam COLON pivotal trial lead investigator.
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