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.
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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