On Friday, the U.S. Food and Drug Administration (FDA) cleared for marketing in the U.S. the first fully disposable duodenoscope– The EXALT Model D Single-Use Duodenoscope. It is intended to provide...

The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed...

The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations...