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Tandem Mobi Now FDA Cleared as World’s First and Only Tubeless AID System with up to Seven Days of Wear

Key Takeaway: Tandem Diabetes Care announced FDA clearance for Tandem Mobi, the first tubeless automated insulin delivery system. This innovative device allows users to wear it for up to seven days, simplifying diabetes management. The new tubeless cartridge and infusion set enhance the existing Tandem Mobi pump's functionality.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA clearance for Tandem Mobi as a tubeless system
  • First and only device of its kind in the world
  • Allows up to seven days of wear
  • Simplifies diabetes management for users

Full Press Release Details

SAN DIEGO--(BUSINESS WIRE)-- #TandemDiabetes--Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of Tandem Mobi for use as the world’s first and only tubeless automated insulin delivery system with up to 7 days of wear.1 A new Tandem Mobi tubeless cartridge and infusion set converts the current Tandem Mobi pump into a tubeless device that can help simplify diabetes management with less frequent si

Frequently Asked Questions

What is Tandem Mobi?

Tandem Mobi is a tubeless automated insulin delivery system for diabetes management.

How long can Tandem Mobi be worn?

It can be worn for up to seven days.

What is unique about Tandem Mobi?

It is the world's first and only tubeless AID system.

Who cleared Tandem Mobi for use?

The U.S. Food and Drug Administration (FDA) cleared Tandem Mobi.

Last updated: Nov 13, 2026