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European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday. Read More
The FDA has finalized a guidance on interactive reviews to include commitments it made in the MDUFA III commitment letter and to expand use of the process. Read More
AdvaMed will make global harmonization a top priority over the next two years, incoming chairman and Covidien CEO Jose “Joe” Almeida said on a Wednesday press call. Read More
Hospira will pay $60 million to settle a class-action lawsuit that claimed the company misled investors about its quality problems, under a plan tentatively approved in federal court. Read More
The first head-to-head comparison of Edwards and Medtronic transcatheter aortic valve replacement (TAVR) technologies ended with a win for Edwards. Read More
House and Senate lawmakers passed separate bills to extend the current sustainable growth rate patch and provide other benefits to diagnostics manufacturers. Read More