The Food and Drug Administration has confirmed that Olympus Corp. did not seek FDA clearance for the latest version of its specialized endoscope, which it began selling in 2010. FDA clearance is required for all substantive updates to medical device sold in the U.S.
Despite the lack of clearance, the FDA said doctors should continue using the device because it’s not clear that a federal review would have prevented the recent infections.
Olympus has now submitted an application for the device that is currently under FDA review
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