Animas said today that the FDA granted pre-market approval for the Animas Vibe insulin pump, featuring Dexcom‘s (NSDQ:DXCM) continuous glucose monitoring sensor technology, in patients age 18 and older.
Johnson & Johnson‘s (NYSE:JNJ) Animas touted the Animas Vibe as the only system integrated with DexCom’s G4 Platinum CGM sensor, saying it provides diabetics with their most recent glucose readings (the system is designed to take a reading every 5 minutes). The Animas Vibe is also designed to report glucose highs, lows and rates of change so patients can fine-tune their insulin regimen, the company said.
"This information complements fingerstick testing results and can be used to help guide immediate and long-term insulin delivery therapy adjustments," Animas said.
"For many people who are insulin-dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management. 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," Animas CMO Dr. Brian Levy said in prepared remarks.
"We are excited to bring Animas Vibe to the U.S., which expands our insulin delivery portfolio and delivers on our promise to provide a range of solutions that help patients perform at their very best," added J&J diabetes solutions president Ty Lee.
Animas said it’s taking orders for the device and expects to begin shipping it out to U.S. patients next month. The Animas Vibe is also available in Europe, Australia, New Zealand and Canada, according to a press release.