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The FDA is blocking several devices manufactured by Global Medical Production of Jiaxing, China, from being imported into the U.S. due to serious quality violations. Read More
The FDA has issued a draft guidance explaining how it defines and distinguishes “counterfeit” devices from the genuine article, as part of its implementation of the Safeguarding Therapeutics Act enacted Jan. 5. Read More
The FDA is looking to regularize the status of devices it has authorized for emergency use during the COVID-19 pandemic and has released two draft guidances — one explaining the transition away from emergency status and another on how the agency’s approach to enforcement will change for the affected devices. Read More
The first biopolymer heart valve, developed by Foldax USA, has passed initial human trials and is ready for deployment into a larger study population, the company said. Read More
The FDA yesterday granted de novo marketing approval to Philips’ CavaClear laser sheath, the first laser-based device approved for the removal of inferior vena cava (IVC) filters when previous removal methods have failed. Read More