The Food and Drug Administration backing Olympus endoscope linked to "superbug"

March 5, 2015 9:09 PM

2 0

The Food and Drug Administration is backing an Olympus endoscope linked to deadly "superbug" infections despite questions about whether the device was sold with proper regulatory approval.

Olympus markets its TJF-Q180V duodenoscope under the FDA's applicable 510(k) clearance guidelines, according to the company, whose American headquarters is in Center Valley. The company said it modified its previously approved duodenoscope in 2010 and determined that FDA policy did not require a new...

Read more

To category page