Tandem gets FDA clearance for remote software update tool

///Tandem gets FDA clearance for remote software update tool
Facebooktwittergoogle_plusredditlinkedinmail

By Lisa Foster-McNulty, MSN, RN, CDE

Wouldn’t it be great to be able to get a software update to your existing insulin pump when your pump company comes out with new innovations rather than having to wait until your pump is out of warranty and you are due for a new pump? 

It’s frustrating when you want the latest and greatest version but have to wait.  Fantasy should be becoming reality sooner than you think!

Tandem Diabetes Care makes the t:slim, t:slim G4, and the t:flex insulin pumps.  They have announced that they have received  FDA (Food and Drug Administration) clearance for the Tandem Device Updater.  This is a tool that is compatible with both Mac and PC computers for the remote update of Tandem insulin pump software. 

Tandem pumps have a touchscreen interface, and this recent FDA clearance makes Tandem the only pump company able to give users access to new pump features outside of the traditional multi-year warranty hardware replacement cycle.  It lets Tandem give its customers access to new innovations faster than what has been possible in the past.  This is important as we move towards the availability of a commercially available artificial pancreas.

The Tandem Device Updater was first used to get the latest t:slim software to users of t:slim pumps that were purchased prior to April of 2015, with beta testing going on over the summer of 2016.  In April of 2015, the updated software, which contained several product updates for convenience and flexibility, started shipping in new t:slim pumps.  The changes include expanded reverse correction functionality, the ability to enter a manual bolus directly in the suggested bolus window, and off-pump cartridge filling.  The plan is that future software enhancements will be made through the Tandem Device Updater as they receive clearance to be distributed commercially.

At the time of this writing, the Device Updater is not commercially available, so it remains to be seen what this will look like when the product is rolled out.  But there is so much potential to using this platform!  Imagine if the FDA approved the Dexcom G5 for use with the t:slim and there was a way to get this technology soon after approval.  How about when the Dexcom G6 is approved?  Perhaps this would be used someday when a closed-loop algorithm becomes available.  Of course, the FDA must approve the release of technologies via the Update Tool, so it remains to be seen how this will unfold.  However, it gives us hope that exciting innovations are in the pipeline.

By | 2016-09-16T20:18:02+00:00 September 16th, 2016|September 2016 Newsletter|0 Comments

About the Author:

Leave A Comment