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Today's Issue of Medical Device Daily

Saturday, August 1, 2015

Today's Headlines

Waking up to valve potential: 'Sleeping giant' Abbott starts to stir Abbott goes after mitral valve space with Tendyne deal, Cephea investment

Recently dubbed the sleeping giant on the M&A front because of its noticeable lack of deal activity in the first half of the year, Abbott (NYSE: ABT) (Abbott Park, Ill.) seemed to awaken from its hibernation on Thursday with an appetite for the massive transcatheter mitral valve replacement (TMVR) market.

Cures, budgets and cures for the budget blues

Everybody thinks they're poor, but Uncle Sam does have an ongoing deficit problem, and these budget issues are showing up in interesting ways of late. Needless to say, these problems are affecting the appropriations process, but there may be an escape hatch, and a couple of items of interest for device makers may be at risk, depending on the outcome. (MDD Perspectives)

Reversal in regulatory pathway? Europe's changes to CE mark suddenly make FDA-first approval seem attractive

PARIS — Later this year, the European Union is almost certain to impose a pre-market authorization procedure for novel high-risk implantable medical devices (Medical Device Daily, July 7 and July 8, 2015).

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