Fresenius Medical Care North America
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Latest From Fresenius Medical Care North America
Leading edge products like mRNA vaccines and CAR-T therapies are not immune from quality problems, nor are immunosuppressives, as US FDA inspections and internal investigations recently found.
News We’re Watching: More Class I Recalls, FDA Expands TAP, Guardant Appeals Patent Verdict, And More
This week, the US FDA labelled several recalls class I, approved an at-home diagnostic for chlamydia and gonorrhea, and announced the expansion of its TAP pilot program. Guardant Health also announced it would appeal a verdict in a patent suit against the company and AdvaMed voiced its continued support for pending breakthrough device legislation.
Toxins that have been shown to cause adverse events in animals – including endocrine dysfunction and male reproductive effects – are emitted by tubing that’s part of Fresenius’ 2008T, 2008K2 and 2008K model devices, the US agency says in a letter to health care providers.
Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
- Medical Devices
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