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Citing continuing confusion among devicemakers regarding borderline products, the UK’s Medicines and Healthcare products Regulatory Agency last month issued guidance clarifying when they qualify as a medical device in the EU. Read More
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
The current kerfuffle around online direct-to-consumer genetic testing service 23andMe.com came out of “a perfect storm” that led to the widespread marketing of such tests, experts say. Read More
Morrisville, N.C.-based Sapheon released one-year data from its European study of the VenaSeal Sapheon Closure System for treatment of venous reflux disease. Read More
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More