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PillCam Colon Now FDA Approved as Adjunct to Incomplete Colonoscopies

PillCam Colon PillCam Colon Now FDA Approved as Adjunct to Incomplete Colonoscopies (VIDEO)

Given Imaging (Yoqneam, Israel) received FDA clearance for its PillCam COLON video recorder, essentially a GoPro for your GI tract. The clearance is intended for patients who had an incomplete traditional colonoscopy and still require a better review of the passageway.

The device measures 12 mm X 33 mm and records video as it moves along the GI tract. It automatically adjusts its frame rate anywhere between 4 and 35 frames per second and simultaneously transmits the photos  to a recording device worn by the patient. The individual frames are then rendered into a video and the physician can review the recording almost as soon as the pill makes its way through the colon.

From the announcement:

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.

For the curious ones, you too can take a fantastic voyage aboard the PillCam COLON:



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