A finger-stick glucose meter in a 2021 file photograph, not the Tandem Mobi pump or its continuous glucose monitor. Photo: Pavel Danilyuk / Pexels.
Tandem Diabetes Care says U.S. regulators have cleared a new cartridge and infusion set that let people wear its existing Mobi insulin pump without tubing. The company plans a full U.S. launch in the first half of 2027.
The clearance was received November 12, according to a filing the company submitted to the Securities and Exchange Commission on Friday. It is a regulatory step, not an announcement that the new supplies are already available.
There is an important limit behind the seven-day wear claim: the infusion set, which delivers insulin under the skin, is cleared for up to seven days. The insulin cartridge is cleared for only three days of use. The clearance does not mean one cartridge can be used for a week.
The new supplies work with existing Mobi pumps. Tandem said customers whose pumps are still under warranty will not need to buy a new pump. The change adds a tubeless choice rather than removing the option to use tubing.
Mobi uses Control-IQ+ software with a compatible continuous glucose monitor. The software uses sensor readings to predict glucose levels 30 minutes ahead and adjusts insulin delivery. It does not replace a person’s active diabetes management.
Access will also depend on insurance. Tandem says the new tubeless cartridges and infusion sets will be sold exclusively through pharmacies for customers with pharmacy benefits. The company estimates that pharmacy coverage for Mobi customers currently reaches about half of insured lives in the United States. That is a company coverage estimate, not a guarantee that a particular patient’s plan will pay.
The system requires a prescription. Tandem warns that using the pump, glucose monitor or other parts outside their instructions can deliver too much or too little insulin, causing low or high blood glucose. Its planned launch date remains subject to the risks described in the company’s filing.
The clearance date and different wear limits are detailed in Tandem’s November 13 SEC filing. Launch, compatibility and pharmacy-access details are in the company’s announcement.
JBizNews Desk | New York
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