Boston Scientific Corporation has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is an FDA-cleared single-use (disposable) duodenoscope that was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device. ...

The US Food and Drug Administration cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses. The Pentax Medical Video ED34-i10T2 model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to ...

GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal Duodenoscope Protective Device, an endoscopic shield for protecting the distal end of a duodenoscope from contamination during ERCP procedures. ScopeSeal  is a single-use disposable infection control device that preserves duodenoscope optics and other key functionality while sealing the ...

ESGE and ESGENA recently issued a statement pertaining to the use of removable caps on duodenoscopes: You may be aware of the recent debate regarding the suggestions by some regulatory authorities (e.g. the US Food and Drug Administration [FDA]) of the need to use removable caps (reusable or single use) on duodenoscopes, and furthermore advocating the development of fully disposable ...

By Chad Terhune This article first appeared January 19, 2018 on Kaiser Health News. A Seattle judge said Olympus Corp. failed to properly disclose internal emails that raised safety concerns about a redesigned medical scope as early as 2008, several years before the device was publicly tied to deadly superbug outbreaks. Citing those “willful discovery violations” by the Japanese device ...