San Diego-based Tandem revealed that it received FDA approval for the Android version of its Mobi mobile app. Clearance brings Mobi — which the company describes as the world’s smallest, durable automated insulin delivery system — to more users. The pump, which pairs with Tandem’s Control-IQ+ algorithm, previously worked with iOS software.
Tandem — one of the largest diabetes tech companies in the world — expects to begin a limited rollout next month, followed by full commercial availability in early 2026. This marks the latest milestone for the company, which continues to expand its offerings and widen its reach within the diabetes patient population.
The company began the year by launching the next-generation Congrol-IQ+ algorithm earlier this year. It followed that up by announcing the future pairing of Tandem systems with Abbott’s under-development dual glucose-ketone sensor and kicking off the launch of its t:slim X2 pump with the Abbott FreeStyle Libre 3 Plus last month.
Now, with the latest FDA clearance in hand, the company believes it can bring its insulin delivery technology to even more people.
Drug Delivery Business News spoke with Tandem Director of Product Marketing Ben Mar to understand the significance of the FDA clearance and discuss the plans for the company down the road.
The following has been lightly edited for space and clarity.
What is the significance of this milestone for Tandem?
Ben Mar: “It is really big for Tandem and it’s really big for people with diabetes in general. Essentially, this is probably the biggest feature that we’re delivering since we launched Mobi. We’re opening up Mobi to about 50% of the population in the U.S. Android users can now get access to Mobi and use their personal smartphone to manage and control their diabetes with Tandem Mobi. It’s an exciting time for us. It’s been a lot of hard work to get this clearance and shortly start the commercialization of it and the availability of it.”
What goes into an FDA submission to deliver the pump’s capabilities on a new operating system?
BM: “It is a lot of work, and that’s why these things don’t happen overnight. As part of the submission, we have to do a lot of what we call the development work. The app needs to be essentially developed and ready to go, and then we also have to do a lot of testing and feedback on the user, just showing that the experience is equivalent and working the same way the iOS version did.
“There is actually, surprisingly, a large amount of variations just between the different phones and the operating systems. While a screen might be the same, the menu commands and the steps, they’re all slightly different, and we need to make sure that, one, they work, but, two, people understand and comprehend those tasks that they’re trying to step through to make sure that it’s performing effectively and in the same way. You’ve got all that documentation that you have to provide and then submit all the testing, everything, showing that it’s working as expected. That’s all part of the review that the FDA does to make sure that this is a safe and effective system.”
How much have people with diabetes been asking for this expansion?
BM: “I don’t have any specifics in terms of numbers, but I would say it’s been the most requested feature since we’ve launched. CGM compatibility is always a big one, but really this has been the number one thing that we’ve been trying to get out there and make available.
“We’ve heard of people buying iPhones so they can get access to Mobi because they’re using Android. Then, we’ve got a long list of people that have been waiting for access to Mobi, which is the smallest durable system available. They’ve been waiting to be able to use it with their Android phone. We’ve got a lot of people. We’ve had lots of phone calls over over the last few months, waiting for it. You generally hear a lot that people are pretty much either iOS or they’re Android users, and they don’t like switching between. So, we’ve got a lot of people just that have been waiting for this, and they’re really happy to use it.
“In terms of numbers, we’re planning to make this available, and in terms of specific handsets, we’re planning to make this available on over 40 handsets in the U.S., when it is fully available. That’s a lot of handsets and it means that the people get access to it. The majority of users are going to be able to get it with their personal smartphone.”
What are some of the details of the launch?
BM: “We’ll start early this year. We have a sign-up form. People that have been waiting — we’ve got a long list — but anyone that’s really interested today, they can sign up, and they’ll be able to get access to the limited rollout. We want people that have been waiting for a while to be some of the first to access it. They can sign up and we’ll contact them as soon as we’re ready to go.”
What about other geographies following the U.S. rollout?
BM: “[There’s no] change on the previous guidance, I believe, and the latest guidance that’s been given is for early next year in terms of wider availability.
“I will say, though, talking about Android — even though it’s about 50% in the U.S., it’s even higher in countries throughout Europe. There is a high Android user population. This really helps us and means that it’s going to be a lot more accessible to people as we go into other countries around the world.”
Tandem keeps finding ways to bring its technology to more people. What’s next?
BM: “John Sheridan, our CEO, on the latest earnings call, just gave a recent update on the Mobi tubeless infusion set. Being able to have Mobi with a tubeless infusion set and the tubeless patch wear option, that’s obviously something that we’ve committed to in delivering next year, and it’s something that we’re working really, really hard on as well.
“You can see the progression, especially on the Mobi side, getting access to smartphones, getting access to a wider range of CGM sensors, and then delivering on a tubeless offering, all under the Mobi system. It’s something that you can see where we’re really busy on it and excited about it.”
“The Mobi tubeless infusion set is also being designed for extended wear. Our goal is to make that up to seven days of wear, which would be the longest available tubeless offering out there today.”
“We only just made commercially available the Abbott FreeStyle Libre 3 Plus sensor on the t:slim X2 pump. That’s available in the U.S. today and w’e’re initiating commercialization efforts around the world. The big one we’re then going to be turning attention to is Mobi with FreeStyle Libre 3 Plus as well. That’ll be coming after this. Then, with the Dexcom 15-day sensor, we plan to support that as well when Dexcom starts rolling that one out, too.”
