News Briefs: PillCam Colon Clearance; CGM For Pediatrics; SGR Reform Bill

FDA granted de novo clearance to Given Imaging Ltd.’s PillCam Colon device for the detection of colon polyps in patients for whom a complete evaluation via optical colonoscopy was not technically possible, the firm announced Feb. 3. It is a win for Medtronic Minimally Invasive Therapies, which announced its plans to buy Given for $860 million in December. (See Also see "Covidien Ventures Into Capsule-Based Endoscopy With Given Imaging Acquisition" - Medtech Insight, 16 December, 2013..) The PillCam device is a disposable capsule containing a miniaturized video camera that is swallowed by the patient, enabling physicians to view the GI tract without the need to sedate the patient. The technology is already FDA-cleared for small-bowel and esophageal imaging, but the colon indication is a bigger opportunity. The approved diagnostic indication is more restrictive than the screening indication originally sought by Given, but analysts believe Covidien’s clinical and regulatory heft could accelerate expanded labeling for the product. (See Also see "Given Imaging’s PillCam Colon 2 Strategy Shift Will Delay Screening Claim" - Medtech Insight, 20 August, 2012..)

“Overall, the colon market could be three times larger ... than small bowel, but significantly broader indications are needed,” Morgan Stanley analysts said in a Feb. 3 research note