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It is important that viral transport media “are appropriately designed and validated prior to distribution to ensure that the transport medium will preserve the viral particles without meaningful degradation that could lead to inaccurate test results,” the agency said. Read More
Equipment operators and items brought into a plant are the two chief reasons for contamination in manufacturing clean rooms, said disinfecting expert Jim Polarine during an FDAnews webinar hosted last week. Read More
Exogenesis’ nanoMesh hernia repair device caused less inflammation than a control implant mesh during evaluations 14 and 28 days after implant, the company says. Read More
The Department of Health and Human Services (HHS) said Wednesday it will spend $650 million in American Rescue Plan funds to strengthen manufacturing capacity for COVID-19 diagnostics, through rapid point-of-care molecular tests, and to increase public access to them. Read More
One of the complaint unit’s chief responsibilities is to maintain complaint files, which are the records documenting all analysis conducted and actions taken when a company receives a complaint about a device. Read More
As part of a major reorganization, General Electric is spinning off its GE Healthcare division as a publicly traded company, the corporation announced this week. Read More
Device trade association AdvaMed has told the federal government that the worldwide shortage of semiconductors continues to create major problems for the industry. Read More
Boston Scientific has won $20 million in a patent lawsuit against Nevro, with a jury in the U.S. District Court for the District of Delaware finding that the defendant device company willfully infringed various Boston Scientific patents for spinal cord therapy technology. Read More
Edwards Lifesciences says that a clinical trial found favorable patient outcomes after six months for its investigational Evoque transcatheter, transfemoral, tricuspid valve-replacement system. Read More
Swiss company Alcon is paying $475 million to acquire device company Ivantis, developer of the Hydrus Microstent for surgical glaucoma, strengthening Alcon’s ophthalmology portfolio. Read More