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OneTouch Vibe Plus Insulin Pump Earns FDA Approval

Animas Corporation, part of the Johnson & Johnson Diabetes Care Companies (JJDCC), announced today that it has received U.S. Food and Drug Administration (FDA) approval, and Health Canada’s authorization for the sale of the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System for the treatment of patients age two and older living with diabetes. The OneTouch Vibe™ Plus is the first and only insulin pump integrated with Dexcom G5® Mobile CGM technology, combining accurate and precise insulin dosing technology from Animas with the most accurate CGM sensing technology from Dexcom. This system will enable patients to see their glucose reading at all times either on their pump or using the Dexcom G5® App on their smart phone, and to deliver the precise amounts of insulin they may need from the pump.

The Dexcom G5® Transmitter collects blood glucose readings from the Dexcom sensor and wirelessly sends them to the patient’s OneTouch Vibe™ Plus Insulin Pump screen and compatible smart device using the Dexcom G5® Mobile System and app. This will enable patients using the pump and their caregivers to access CGM data wherever it is most convenient for them, and to make informed diabetes management decisions. In addition to the primary smart device, glucose data can be shared with up to five people utilizing the Dexcom Follow App.

“People living with diabetes will no longer have to pull out their pump to read their glucose readings. By having constant access to glucose readings on their pump and now their smart devices, the OneTouch Vibe™ Plus will give people with diabetes greater flexibility and discretion,” said Brian L. Levy, MD, FACE, Chief Medical Officer of JJDCC and Vice President of Worldwide Clinical Affairs for LifeScan, Inc.  “This unique connectivity combined with the OneTouch Vibe™ Plus System’s patented technology that delivers insulin with exceptional accuracy and precision will help patients—even the most insulin-sensitive patients—stay in their target glucose range.”

In addition to being the only Dexcom G5® integrated system cleared by regulatory authorities, it also remains the only integrated system approved for children as young as age two. The enhanced connectivity enables parents and caregivers to continuously access their children’s blood glucose to help make treatment choices. “This system will offer kids living with diabetes a sense of freedom and will provide loved ones and caregivers with an insulin delivery and monitoring system that they can trust,” says John Wilson, Worldwide Vice President of Insulin Delivery, Animas Corporation.

Animas is evaluating launch timing for the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System in the U.S. and Canada.

With this approval, the OneTouch Vibe™ Plus Insulin Pump – and all Animas Corporation insulin delivery products moving forward – will join the iconic OneTouch® family of diabetes solutions. In the U.S., OneTouch® brand products are recommended by more endocrinologists and primary care physicians than any other brand1. Globally, more than 15 million people depend on OneTouch® brand products to help them manage their diabetes.

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