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Top Device Stories Of 2011: Living In A State Of Transition

Executive Summary

EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry.

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Regulatory News In Brief

FDA's device center issues a significant draft guidance on the 510(k) program, plus a draft on appeals processes open to sponsors. More end-of-the-year regulatory developments.

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