December 1, 2014

Animas® Vibe™ Insulin Pump and CGM FDA Approved

The Vibe has been approved by FDA!


Integrated System Streamlines Diabetes Management for Patients 
CHESTERBROOK, Pennsylvania, Dec. 1, 2014 / PR Newswire / — Animas Corporation today announced FDA approval of the Animas® Vibe™ insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. As the first and only integrated system featuring Dexcom G4® PLATINUM sensing technology with proven accuracy, Animas® Vibe™ allows patients to view glucose data and administer insulin right from the pump; simplifying and aiding their ability to make more informed decisions to fine tune insulin delivery and manage their diabetes. 
Animas is now accepting orders for Animas® Vibe™ and anticipates shipment to patients to begin in January 2015. For more information, visit www.animas.com

More: http://www.multivu.com/players/English/7312951-animas-corporation-vibe-insulin-pump-continuous-glucose-monitoring-system-fda-approved/ 

8 comments :

  1. For the record: 19 months at the FDA. Although it's important to point out, the FDA only had all requested data since roughly February 2014 so really the regulators ONLY spent 9 months on this. THAT is something most will gloss over sadly, but I believe the FDA deserves credit for quick action on this once they got everything they'd wanted (and really, should have been sent in from the start). Figured you would appreciate this.

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  2. Thanks Mike. I always appreciate your comments.

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  3. Did you know I have your post from April 2013 in my feed reader. I was originally counting the days but eventually just kept it for posterity.

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    1. Thanks Sara.

      We were hoping for this a few pumps ago too.

      Like eggs, don't count on FDA approval until it hatches, right?

      All my best.

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  4. Wasn't part of the delay (in filing) because Animas originally wanted approval for pediatric use?

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  5. That isn't what i have heard but that isn't to say it wasn't so. Typically a peds. application follow that adult one as it is a faster path to market for the majority of the market.

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  6. That's what the rep told us - when Animas still had reps in our area.

    Curious if Dexcom will keep their latest software updates for their own device, of if that will come to the Vibe as well.

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  7. Thanks for sharing this info about this insulin pump.

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