FTNW: Animas/Dexcom Vibe gets CE Mark
From the News Wire: Animas Dexcom CGM combo get approved in Europe. Here are the highlights and a link:
WEST CHESTER, PA, June 2, 2011 /PRNewswire/ — Animas Corporation announced today the receipt of CE Mark approval for Animas® Vibe™, the first and only continuous glucose monitoring (CGM)-enabled insulin pump system with Dexcom G4™ CGM technology. Animas® Vibe™ brings together the unique features of an Animas® insulin pump and the convenience of Dexcom CGM, which is the only sensor approved for up to seven days of wear. More here.
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1 comment:
What does getting the CE Mark mean in terms of the approval process for Europe? I'm guessing it has no influence on the FDA process.
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