Dignitana AB announced that the company has submitted for review an application to the US Food and Drug Administration (FDA) Center for Devices and Radiologic Health for approval of the DigniCap™ System. Dignitana engaged the Clinical Research Organization (CRO) Target Health Inc., with offices in New York, in 2011, and Dignitana has been working in close collaboration with Target Health to interact with FDA, conduct the pivotal clinical trial and prepare the FDA application.
