Memorandum

Tandem receives FDA clearance for Device Updater, enabling online software update of insulin pump software – July 14, 2016

Today, Tandem announced FDA clearance of its Device Updater, an online tool for updating its insulin pump software remotely (formerly called Project Odyssey). Tandem will do a beta launch in the next four to six weeks, and a wider launch will occur later this year. The clearance comes just a couple weeks late of the guidance for “2Q16,” but a pretty quick review following the 4Q15 submission. We’re very glad to see the Device Updater is both PC/Mac compatible and the website is already up and running and taking names. The first software enhancement will allow early t:slim customers to access the updated t:slim software that began shipping with new pumps in April 2015 – this included a number of changes based on customer and HCP feedback, including a streamlined cartridge change process (great to see this being addressed, as it was a criticism in diaTribe’s test drive back in 2012 and an outstanding thing to get fixed). Future software improvements will be implemented through the Tandem Device Updater “as they are cleared for commercial distribution.” Today’s announcement relates this to Tandem’s artificial pancreas efforts, bringing potential for faster innovation rollout– could current t:slim users eventually update their pump software and make it AP-enabled? (There is some regulatory nuance here, as we’ve noted in the past.) Or, as AP algorithms improve, users could quickly and easily update their pump’s software. We see this as an excellent 21st century way to keep insulin pump software up to date, to roll out innovations outside the four-year hardware cycle, and a low-cost way for Tandem to improve the product without shipping expensive new pumps. We hope all diabetes devices move in this direction, and as more and more functionality gets shifted to mobile apps, this should happen naturally. Dexcom was the first diabetes device company to really benefit from this, launching its Software 505 algorithm update as an online receiver upgrade in Fall 2013. Awesome.

-- by Adam Brown and Kelly Close