FDA downgrades Given Imaging's PillCam

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.
Covidien, Food & Drug Administration (FDA), Given ImagingNews Well, 510(k), Endoscopic / Arthroscopic, Food & Drug Administration (FDA), Imaging, Regulatory/Complianceread more

Source: Mass Device - May 16, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news