OneTouch Vibe Plus Insulin Pump receives FDA approval and Health Canada marketing license
Animas has received approval from the US Food and Drug Administration (FDA) and Health Canada to sell the OneTouch Vibe Plus insulin pump and continuous glucose monitoring (CGM) system to treat patients with diabetes.
The OneTouch Vibe Plus is an insulin pump integrated with Dexcom G5 Mobile CGM technology, which is a combination of the insulin dosing technology from Animas along with accurate CGM sensing technology from Dexcom.
It allows patients and physicians to access CGM data convenienctly on the pump or through the Dexcom G5 app on a smartphone and make informed diabetes management decisions. The data can also be shared with a maximum of five people using the Dexcom Follow app.
LifeScan's worldwide clinical affairs vice-president and JJDCC's chief medical officer Brian Levy said: "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.
"This unique connectivity, combined with the OneTouch Vibe Plus System's patented technology that delivers insulin with exceptional accuracy and precision, will help even the most insulin-sensitive patients stay in their target glucose range."
The company is evaluating launch timing for the OneTouch Vibe Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System in the US and Canada. The approval will now see the OneTouch Vibe Plus Insulin Pump and all Animas insulin delivery products join the OneTouch family of diabetes solutions.
Image: OneTouch Vibe Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System. Photo: courtesy of Prnewswire.