FDA Clears the Redesigned Olympus Duodenoscope

BREAKING NEWS  FDA clears a modified Olympus TJF-Q180V duodenoscope FDA Press Release: “FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk” (January 15, 2016) Olympus Press Release: “Olympus Receives 510(k) Clearance for TJF-Q180V Duodenoscope” ALSO BREAKING NEWS Olympus Read More …

FDA Orders Endoscope Manufacturers to Perform Safety Studies

October 6, 2015 — Yesterday the U.S. Food and Drug Administration (FDA) ordered the three manufacturers of certain specialized medical endoscopes sold in the U.S. to perform “postmarket” surveillance studies.  This order was made public via a FDA News Release....

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USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”

Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might have infected or otherwise harmed a patient — are filed Read More …