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Today's Issue of Medical Device Daily

Tuesday, September 1, 2015

Today's Headlines

Another day, another Google partnership: Google expands reach into diabetes care market with Sanofi partnership

Google's (Mountain View, Calif.) life sciences team is once again delving into the diabetes monitoring and treatment space, this time through a partnership with Sanofi (Paris). The companies will work on better ways to collect, analyze and understand multiple sources of information impacting diabetes. The move comes just a few weeks after Google reported entering into an agreement with Dexcom (San Diego) to develop smaller and more affordable continuous glucose monitoring products (Medical Device Daily, Aug. 12, 2015).

Continuous monitoring; The Medicare CGM coverage fight

Continuous glucose monitors have been around for a few years, but the Centers for Medicare & Medicaid Services has had little to say about them to date. NHIC, a Medicare administrative contractor that seems to serve as the agency's point for durable medical equipment, has declared that CGMs are not coverable, and the coverage debate is getting noisier every day. (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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