The FDA has sent Given Imaging, an Israeli company famous for its line of capsule endoscopes, a “not substantially equivalent” (NSE) letter regarding its 510(k) application to market PillCam(R) COLON in the US.
The company’s president and CEO Homi Shamir is not happy:
“While we are disappointed by the FDA’s decision we are evaluating our options to bring PillCam Colon to the US 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.”