Given Imaging, a global medical device manufacturer based in Yokneam, Israel, announced that it had submitted applications for the approval of its capsule endoscopy system. The company is pursuing approval for its PillCam Colon 2 system with the United States Food and Drug Administration’s direct de novo device approval pathway.
Given Imaging’s PillCam Colon 2 system is designed to help patients with minimize the risk of complications and other adverse events during an incomplete or high risk optical colonoscopy. The system reduces many of the risks associated with double-contrast barium enema and CT colonography procedures.
Homi Shamir is CEO and president of Given Imaging. In a press release, he stated, "Filing for FDA clearance is another important milestone for Given Imaging in advancing our efforts to commercialize PillCam Colon 2.” He continued, "We believe that PillCam Colon 2 meets a significant unmet need for a non-invasive imaging tool for visualization of the lower GI tract for physicians and their patients who are unable to undergo colonoscopy or in cases of an incomplete colonoscopy."
According to data from the National Cancer Institute, an estimated 147,000 people in the United States are diagnosed annually with colorectal cancer. However, only 50 percent of at-risk people in the United States undergo a recommended colonoscopy every year. With Given Imaging’s new system, many of the complications associated with this diagnostic procedure may be a thing of the past.