ADVERTISEMENT

United States Minor Outlying Islands

Discontinued Endologix AAA Graft Device Singled Out In Updated FDA Alert

Discontinued Endologix AAA Graft Device Singled Out In Updated FDA Alert

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.

'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

US Policy Quick Bits: Point-Of-Care Dx, Bundling, And Chatter On The Hill

US Policy Quick Bits: Point-Of-Care Dx, Bundling, And Chatter On The Hill

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look at key US policy developments and events that unfolded over the past week, including a controversial CLIA waiver draft guidance from FDA and the Trump administration's new direction on bundled payment models.

Warning Label For Gadolinium Contrast Agents Gets US FDA Panel Backing

Warning Label For Gadolinium Contrast Agents Gets US FDA Panel Backing

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.

Consumer Health Weekly Trademark Review April 18, 2017

Consumer Health Weekly Trademark Review April 18, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.

Consumer Health Weekly Trademark Review April 18, 2017

Consumer Health Weekly Trademark Review April 18, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.