Tandem Diabetes Care plans to file a 510(k) submission with the Food and Drug Administration this quarter for its first tubeless insulin pump.
The device, a version of the company’s small, durable Mobi pump, would be the first tubeless insulin pump with the ability for extended wear, CEO John Sheridan told investors in a Thursday earnings call. Users would be able to switch between a traditional tubed insulin pump and tubeless wear.
Sheridan said the company expects to receive FDA clearance in the second half of the year.
“There's some uncertainty with the FDA, but you know, they've been doing a really nice job lately to get things done quickly,” Sheridan said.
The company did not include any sales from the tubeless device in its forecast for the year because Tandem does not include new products until they’re in the market, the CEO said. Tandem would introduce the new device through a phased process, starting with small groups, before a full commercial launch.
Sheridan sees the tubeless option as giving Tandem a competitive advantage in a market he estimates is growing by roughly 20%. Currently, the market is dominated by insulin patch pump maker Insulet.
Tandem is also working on a fully closed loop system, as its competitors develop their own closed loop devices. Unlike the automated insulin delivery systems currently on the market today, fully closed loop systems would not require user input for bolusing or carb-counting. Tandem is making progress toward a pivotal study of that system, which it plans to start this year, Sheridan said.
Tandem shipped a record 29,000 pumps worldwide in the first quarter, including 19,000 in the U.S. Tandem also launched a pay-as-you-go model in U.S. pharmacies during the quarter.
The company said it is grappling with infusion set supply constraints due to a supplier’s capacity challenges. The problem started in the fourth quarter of 2025, and Sheridan expects it will take another quarter or two to resolve.
While just a few products were affected, the impact has been significant for patients and healthcare providers.
“We are doing everything we can to be creative,” Sheridan said. “We are looking for options in terms of lengths, colors, you name it, to see if we can provide intermediate solutions until this is taken care of.”
CFO Leigh Vosseller said the supply constraints had a modest impact on Tandem’s U.S. and international first-quarter results.
