Disposable Endoscope Shield Gains FDA Clearance

October 25, 2019

GI Scientifics’ ScopeSeal, a disposable protective device for the distal end of duodenoscopes,  received clearance from the FDA.

The device shields the end of duodenoscopes from contamination during endoscopic retrograde cholangiopancreatography (ERCP) procedures, which enable physicians to examine a patient’s bile and pancreatic ducts.

Cleaning and disinfecting duodenoscopes is difficult because of their advanced technology, which involves intricate moving parts, said Romney Humphries, a clinical professor of pathology at the University of Arizona.

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