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China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More
An FDA action plan on subgroup analysis, currently in the works, could make device trials excessively large and expensive by imposing unnecessary requirements, AdvaMed warns. Read More
Manufacturers of diagnostics designated for research or investigational use only should limit their use to the earliest stages of device development, Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said during a Wednesday webinar sponsored by the American Association for Clinical Chemistry. Read More
Royal Philips said Tuesday it had reached an enrollment goal of 2,500 patients in its Sleep Apnea cardioVascular Endpoints (SAVE) trial. Preliminary results are expected in 2016. Read More