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The EU’s Medical Device Coordination Group (MDCG) has released new guidance and templates to help devicemakers in filing the newly-required Periodic Safety Update Reports (PSURs) based on postmarket surveillance. Read More
AdvaMed has filed an amicus brief with the U.S. Supreme Court seeking reversal of a California appeals court’s $300 million ruling against medical device maker Ethicon, arguing that the court applied the state’s consumer protection laws too broadly. Read More
The FDA has deemed the Oct. 27 recall by Teleflex and subsidiary Arrow International of two central venous catheter kits as Class 1 because of the risk of serious injury or death. Read More
A federal court in California has dismissed all claims against RST-SANEXAS by Vanguard Clinic and several other plaintiffs about the company’s alleged misleading statements about insurance reimbursement for services for the company’s neoGen pain management devices.
The technology can enable surgeons to limit instrument movement based on a two-dimensional projection during surgery combined with pre-operative imaging.
AdvaMed, joined by eight health advocacy groups, sent a letter to Congressional committee leaders urging year-end passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which was dropped from the user fee reauthorization package passed Sept. 30.