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The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
Varian Medical Systems will pay the University of Pittsburgh $35 million to settle claims that its Real-Time Position Management device infringed on a patent held by the university. Read More
With Brazil’s new antibribery law casting a sharper focus on questionable business practices, local industry groups are joining with U.S. trade group AdvaMed to harmonize ethical behaviors between devicemakers and healthcare professionals. Read More
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More
European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday. Read More