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The FDA has drawn mixed reactions to its draft guidance on reducing healthcare disparities in its Breakthrough Devices program, including support for creating greater flexibility for entry into the program, but also concerns about approvals that might lack sufficient evidence and ultimately jeopardize patient safety. Read More
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.