dilluns, 11 de gener del 2016

FDA approves J&J’s Animas Vibe insulin pump & CGM for kids

Johnson & Johnson Animas Corp

Johnson & Johnson‘s (NYSE:JNJ) Animas Corporation subsidiary said today the FDA approved its Animas Vibe insulin pump and continuous glucose monitoring system for children and adolescents ages 2 to 17.

The Animas Vibe system works with integrated (NSDQ:DXCM) G4 platinum CMG technology and is the only system cleared for patients as young as 2, the company said.

“CGM-enabled systems, like the Animas Vibe system, provide patients with a more complete glucose picture, which is acutely important for children since they might not always be aware of the symptoms associated with high or low blood sugars. The approval of the pediatric indication for Animas Vibe system enables parents and caregivers to both deliver insulin precisely, and monitor glucose trends accurately in children as young as age two with one integrated device,” Animas chief medical officer Dr. Brian Levy said in a press release.

The Animas system allows patients and caregivers to access and view glucose data and administer insulin through the pump remotely to allow for more careful management of diabetes, the company said.

“It’s been our goal as a company to not only develop the best treatment solutions available, but also ensure that every member of the diabetes community, including children, may access these tools. We’re thrilled that the FDA approval of this new indication for the Animas Vibe System for the first time now allows children as young as age two access to a CGM-enabled pump,” Animas insulin delivery worldwide veep  John Wilson said in a prepared statement.

The company said it is currently accepting orders and anticipates shipments to patients beginning this month.

The post FDA approves J&J’s Animas Vibe insulin pump & CGM for kids appeared first on MassDevice.



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