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SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR). Read More
The European Commission released new guidance explaining how Legacy Devices will be identified in the Eudamed database and how their unique device identifiers will be generated and assigned. Read More
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Read More
The FDA has named Kevin Fu as acting director of medical device cybersecurity within the Center for Devices and Radiological Health (CDRH) — a newly created position in response to the agency’s growing concerns about cybersecurity threats. Read More
Health officials are using new tools to gather postmarket safety data on COVID-19 vaccines, including a new early warning system called V-Safe. Read More
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Read More
Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods. Read More
The FDA’s Circulatory Devices Advisory Committee voted 14 to 3 in a Feb. 17 meeting that the benefits of Becton Dickinson’s Lutonix 014 drug-coated balloon don’t outweigh the risks for the proposed indications for use. Read More
Priority Healthcare will pay Roche Diagnostics $43.3 million to settle a lawsuit alleging that it fraudulently submitted claims to insurers and pharmacy benefit managers for Roche’s Accu-Chek blood glucose test strips that put Roche on the hook for tens of millions of dollars. Read More
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Read More
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Read More