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:
Product page: PillCam COLON…