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FDA grants approval for Animas Vibe insulin pump and CGS system

MDBR Staff Writer Published 02 December 2014

The US Food and Drug Administration (FDA) has granted approval for Animas Vibe insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older.

The integrated system features Dexcom G4 Platinum sensing technology and helps patients to view glucose data and administer insulin right from the pump.

The system offers patients with their latest glucose readings on the pump screen and a complete view of glucose highs, lows, and rates of change over time, and this information complements fingerstick testing results, which can be used to help guide immediate and long-term insulin delivery therapy adjustments.

Animas chief medical officer Dr Brian Levy said: "For many people who are insulin dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management.

"We are pleased to now offer people with diabetes in the US a solution with CGM technology that provides the ability to make more informed decisions to manage their disease, which can ultimately improve blood glucose control."

According to the company, the system provides precise insulin dosing with a low basal increment of 0.025U/hr across all available ranges (0.025U/hr to 25.00U/hr) and a low bolus increment of 0.05U across all available bolus ranges (0.05U to 35.00U).

Johnson & Johnson Diabetes Solutions vice-president Ty Lee said: "We are excited to bring Animas Vibe to the US, which expands our insulin delivery portfolio and delivers on our promise to provide a range of solutions that help patients perform at their very best."