FDA medical device regulators put a lower-risk label on Covidien subsidiary Given Imaging’s PillCam ingestible endoscopic camera. Covidien (NYSE:COV) subsidiary Given Imaging landed a victory with FDA medical device regulators who agreed to downgrade the PillCam capsule endoscope to a lower-risk classification. The FDA bumped PillCam down to a Class II device with establishment of special controls, lowering the bar for review of the device from the premarket approval pathway to the 510(k) premarket notification pathway.
Help employers find you! Check out all the jobs and post your resume.
