Noninvasive Alternative to Colonoscopy Wins Partial FDA Approval

A novel-imaging device that is marketed as a noninvasive alternative to colonoscopy has been cleared for use as a tool to screen the large intestine for polyps and other early signs of colon cancer by the US Food and Drug Administration (FDA).

The Given Imaging Ltd. (Yokneam, Israel) PillCam Colon received clearance for sale in Europe (CE marking) in September 2009 and has been commercially available throughout Europe, Latin America, Canada, and parts of Asia.

The Food and Drug Administration has now approved PillCam Colon for patients who have experienced an incomplete colonoscopy. Given Imaging has estimated that approximately 750,000 patients in the US are not able to complete the colonoscopy procedure each year, due to anatomy issues, previous surgery, or various colon diseases.

Analysts estimate that sales of PillCam Colon could grow to over 60 million USD in North America by 2019, with room for expansion as the technology improves.

"Given's management understands that that traditional colonoscopy is the gastroenterologist's bread and butter right now," said MorningStar (Chicago, IL, USA) analyst Debbie Wang. "So they did not want to do anything that would position this as a substitute. Given's PillCam costs USD 500, significantly less than the USD 4,000 for a colonoscopy. Eventually, doctors may use the device to attract adults who avoid regular screenings due to fears of pain, embarrassment, and general discomfort."

The [US] Centers for Disease Control and Prevention's guidelines currently recommend regular colonoscopies beginning at age 50 and continuing until age 75, though the majority of American adults do not follow the recommendations.

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