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Tandem’s Mobi pump wins FDA clearance for 7-day tubeless wearable set

November 13, 2026 By Conor Hale

Tandem Mobi tubeless
The Mobi with tubed and tubeless options. [Image courtesy of Tandem Diabetes Care]
Tandem Diabetes Care (Nasdaq: TNDM) has secured an FDA clearance for a tubeless version of its miniaturized automated insulin delivery system.

The Tandem Mobi’s new cartridge and infusion set converts the pump into a device that can be worn on the skin for up to a week, beating Insulet Omnipod 5’s wear time of 3 days.

Its full U.S. commercial launch is scheduled for the first half of next year, exclusively through pharmacy channels. Current in-warranty Mobi users will not need a new pump, just the compatible accessories — according to the company, Mobi was designed from the start to work with different wear options.

First launched in 2024, the smartphone-controlled pump carries a 200-unit insulin cartridge and a physical button for bolus delivery. Less than half the size of the company’s t:slim X2, the Mobi was built to be clipped onto clothing or placed on the body with tubes and an adhesive sleeve.

Related: Tandem wins FDA nod to pair Mobi pump with Android smartphones

Clearance of the tubeless Mobi was listed as one of the main remaining priorities of the company’s retiring CEO, John Sheridan. Last week Tandem announced that he would be succeeded this month by Jeannette Banks, former chief of GE HealthCare’s patient care solutions business.

Meanwhile the t:slim X2 collected multiple green lights in Canada this week, adding its use in type 2 diabetes and in pregnancy with type 1 diabetes. Health Canada also approved the pump’s use with Abbott’s FreeStyle Libre 3 Plus continuous glucose monitor.

Filed Under: Diabetes, Food & Drug Administration (FDA) Tagged With: Tandem Diabetes Care, wearables

IN CASE YOU MISSED IT

  • Tandem’s Mobi pump wins FDA clearance for 7-day tubeless wearable set
  • Senseonics delivers ‘breakout quarter’ more than doubling Eversense 365 revenue
  • Tandem Diabetes Care names successor as CEO Sheridan retires
  • MiniMed names new CMO ahead of planned retirement
  • Insulet earnings trounce Q3 estimates as it narrows guidance

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