Novel Colon Camera Pill Obtains FDA Clearence
Yoqneam, Israel - Given Imaging Ltd, a world leader in GI medical devices and pioneer of capsule endoscopy, announced yesterday that the U.S. Food and Drug Administration (FDA) has cleared PillCam COLON as a new modality to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.
As previously announced at Digestive Disease Week in May 2013, Given Imaging conducted an 884-patient, 16-site clinical trial studying the accuracy and safety of PillCam COLON 2 compared to optical colonoscopy in detecting adenomas 6 millimeters or larger. Results from this clinical trial demonstrated that the sensitivity for PillCam COLON was 88% and specificity was 82% in detecting adenomas at least 6 millimeters in size.1 The FDA based its clearance decision on an analysis of this clinical trial data that used a more restrictive methodology for matching polyps. In this analysis, which was conducted on hyperplastic polyps and adenomas, the positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81% for polyps at least 6 millimeters in size.2 Continue>
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