The US FDA has identified a recall of Covidien catheters due to a hub defect as class I. The agency’s most serious designation is yet another for the company, which has recently recalled several devices.
The Food and Drug Administration has hit Medtronic with yet another class I recall, this time for more than 1 million catheters under its Covidien subsidiary.
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FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.
