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The FDA has unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
Consolidation of the orthopedics devices space continued Oct. 27 as Wright Medical announced plans to merge with Tornier. The all-stock transaction has a combined value of approximately $3.3 billion. Read More
The Australia government plans to fast-track approvals of promising new medical technologies and conduct joint reviews with trusted foreign regulators as part of a broad effort to streamline the country’s device approval process. Read More
The Department of Justice said Wednesday that Biomet and its EBI subsidiary will pay the U.S. government more than $6 million to settle False Claims Act allegations. Read More
Three months after the EU’s RoHS 2 deadline, Stryker has reviewed more than 600 products and dealt with “significant” costs to comply with the regulations. Fortunately, the company has had a relatively easy time finding alternative components when necessary. Read More