FDA and Health Canada approve J&J’s OneTouch Vibe Plus insulin pump with Dexcom G5 integration – December 20, 2016

Today, J&J Animas announced FDA approval and Health Canada license of the OneTouch Vibe Plus insulin pump with Dexcom G5 integration. Animas “is evaluating launch timing” in the US and Canada; we might guess a launch sometime in 2017 would happen. The CGM-integrated pump is approved down to age two (the youngest available), represents the first approved G5 integration, and will allow patients to view CGM data on either the Dexcom G5 app or pump screen (the G5 transmitter can send data to two devices) – we’re not sure if J&J will launch its own smartphone app, or if the Dexcom app will show insulin on board from the pump. Presumably OneTouch Vibe Plus now has Bluetooth built in, though it is not mentioned in the press release. This product was not ever disclosed on a J&J quarterly call, though we learned in a conversation with J&J that it was submitted to FDA in June – that reflects a ~6-7 month review, or three times faster than the Vibe with G4’s ~20 month review – but closer to the Medtronic record three-month review for the 670G. This pump is a critical update for J&J, who brings its CGM integration up to speed with Dexcom’s latest transmitter, builds Bluetooth into the pump, likely beats Tandem’s t:slim X2 G5 to market (FDA submission by end of 2016), and completes a key stepping stone on the way to J&J’s hypoglycemia-hyperglycemia minimizer (pivotal under discussion with FDA; launch expected in late 2018-early 2019). We are disappointed to see the OneTouch Vibe Plus’ user interface has not been updated much from the previous Vibe, which does put Animas behind Tandem’s t:slim X2 and Insulet’s upcoming OmniPod Dash on this front (for some, this is the “cool factor”). Today’s press release also shared that Animas products going forward will carry the OneTouch brand name, including this pump.  


-- by Adam Brown, Brian Levine, and Kelly Close