Given Not Given FDA Approval

pillcam.jpgGiven Imaging’s new PillCam COLON was not approved for commercial distribution by the FDA on February 18, even though it’s been approved for commercial use in Israel and Europe. The Israeli company develops, produces and markets innovative, patient-friendly products that detect gastrointestinal disorders. The PillCam COLON is a new product based on the PillCam Platform. It’s a tiny disposable video camera in a capsule that can be injested by a patient and used to view their colon. According to Given over 600,000 patients have benefited from PillCam technology.

Given CEO Homi Shamir: “While we are disappointed by the FDA’s decision we are evaluating our options to bring PillCam COLON to the U.S. market as quickly as possible. We recently launched PillCam COLON in Europe and in other countries, and we are working closely with leading GI clinicians to determine its optimal role in patient care. On a parallel track and consistent with our commitment to innovation, we are accelerating development of a next generation colon capsule.”

For more info check out the press release.