Tandem Diabetes Care plans FDA submission for first tubeless insulin pump this quarter

Tandem Diabetes Care announced plans to submit a 510(k) to the FDA this quarter (Q2 2026) for its first tubeless insulin pump (a version of the Mobi pump with extended wear), which would be the first device allowing users to switch between tubed and tubeless configurations. Expected FDA clearance in the second half of 2026. The tubeless market is currently dominated by Insulet (Omnipod). This follows Tandem's record Q1 2026 with 29,000+ pumps shipped worldwide and the recent Control-IQ+ pregnancy approval.