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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
Despite — or in part because of — COVID-19 challenges, the FDA’s Center for Devices and Radiological Health (CDRH) cleared a record 132 novel devices in 2020, surpassing its previous record of 106 in 2018. 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 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
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
A strategy President Joe Biden outlined on the campaign trail to deal with U.S. supply chain vulnerabilities for critical products, including pandemic-related supplies, is likely to be put into effect via executive order within weeks. Read More
The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and diagnostic tests, and to help lower-income nations obtain them. Read More