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US FDA says that previously identified elevated risks of type III endoleaks from endovascular aneurysm repair systems appears to be linked to a specific, no-longer-sold device, Endogix's AFX with Strata system.
The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.
A concise look at key US policy developments and events that unfolded over the past week, including a controversial CLIA waiver draft guidance from FDA and the Trump administration's new direction on bundled payment models.
Advisory committee agrees that risks of gadolinium retention in the brain and other organs need further study; actor Chuck Norris' wife was among several patients who testified of devastating medical problems following administration of agents.
Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.
Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.