FDA Approves Animas Vibe Insulin Pump and Continuous Glucose Monitoring System

Animas Corporation has announced Food and Drug Administration (FDA) approval of the Animas Vibe insulin pump and Continuous Glucose Monitoring (CGM) system.

Animas Corporation has announced Food and Drug Administration (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.

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

CGM technology measures glucose levels every five minutes and provides real - time glucose values, as well as trend information. CGM has been shown to improve glycemic control in adult patients 25 years and older via lower HbA1c levels, less frequent hypoglycemia, and reduced glucose variability.

“For many people who are insulin dependent, diabetes is a demanding disease that can require day- to-day and hour -by-hour management.

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We are pleased to now offer people with diabetes in the U.S. 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,” said Dr. Brian Levy, Chief Medical Officer, Animas Corporation.

Animas Vibe also offers precise insulin dosing with a low basal increment of 0.025 U/hr across all available ranges (0.025 U/hr to 25.00 U/hr) and a low bolus increment of 0.05 U across all available bolus ranges (0.05 U to 35.00 U). Animas Vibe users can also personalize dosing by choosing individual insulin - to-carb ratios, insulin sensitivity factors, and blood glucose targets in 30-minute increments with up to 12 personal settings.