J&J’s Animas wins FDA, Health Canada nod for OneTouch Vibe Plus insulin pump & CGM

Johnson & Johnson‘s (NYSE:JNJ) Animas Corporation subsidiary said today it won FDA approval and Health Canada authorization for its OneTouch Vibe Plus insulin pump and continuous glucose monitoring system.

The OneTouch Vibe Plus features integration with Dexcom‘s (NSDQ:DXCM) G5 mobile CGM, and is designed for diabetes patients age 2 and older, the company said. System users can check their glucose readings at all times on either their pump or through the Dexcom G5 smartphone application.

“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 patients—even the most insulin-sensitive patients—stay in their target glucose range,” JJDCC chief medical officer Dr. Brian Levy said in a press release.

The company said it is currently “evaluating launch timing” for the products in both the U.S. and Canada.

“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,” Animas insulin delivery worldwide veep John Wilson said in prepared remarks.

In October, Johnson & Johnson reportedly warned patients of a small risk that hackers will target its Animas OneTouch Ping insulin pump, after learning of the bug causing the potential cybersecurity risk.

There haven’t been any reports of actual attempts to hack the Animas OneTouch Ping device, company executives told Reuters about what’s believed to be the 1st instance of a medical device company warned patients about the potential for a malicious hacking attack.

The post J&J’s Animas wins FDA, Health Canada nod for OneTouch Vibe Plus insulin pump & CGM appeared first on MassDevice.

from MassDevice http://ift.tt/2hRwaPq