Tandem Diabetes Care wins FDA clearance for tubeless Mobi set worn up to 7 days
The new supplies work with existing pumps, with a U.S. launch planned for the first half of 2027 and access limited to pharmacy benefits.
Adrian Kessler
Tubeless infusion-set wear of up to seven days has received U.S. Food and Drug Administration clearance as Tandem Diabetes Care, Inc. NASDAQTNDM announced on Friday new Mobi supplies compatible with its existing pump. Full U.S. commercial launch is planned for the first half of 2027.
The system's Control-IQ+ software is labelled for type 1 diabetes from age two and type 2 diabetes from age 18. According to Tandem's product page, the tubeless infusion set is cleared for up to seven days of wear, while the insulin cartridge is cleared for three days of use.
Tandem is a San Diego-based global diabetes-device manufacturer that sells automated insulin-delivery pumps. The clearance adds a tubeless option to Mobi while preserving the option to use tubing.
Shares closed at US$17.51 on Nasdaq at 4:00 p.m. EST on Nov. 12, according to NASDAQTNDM, before Friday's clearance announcement.
Customers with an in-warranty Mobi will not need a replacement pump to use the new supplies, according to the Nov. 13 release. Existing pumps are already compatible, so access for those customers depends on obtaining the new cartridge and infusion set.
"The Tandem Mobi insulin pump was originally designed to make different wear options possible, which now includes a tubeless option with up to 7 days of wear," chief executive John Sheridan said in the release.
Mobi uses continuous glucose monitor readings to predict glucose levels 30 minutes ahead and automatically adjust insulin delivery. The prescription-only system still requires active diabetes management, Tandem cautions.
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Insulet Offers Up to Three Days of Tubeless Delivery
The direct tubeless competitor is Insulet Corporation NASDAQPODD, whose Omnipod 5 product page, checked Nov. 13, describes up to three days of automated insulin delivery. Its labelled population also includes people with type 1 diabetes from age two and adults with type 2 diabetes.
Omnipod 5 is available through the pharmacy, according to Insulet's product page. Tandem is entering that channel with a longer infusion-site wear interval, although its three-day cartridge limit means the insulin supply still needs more frequent attention.
The incumbent's sales show the scale of the market Tandem is targeting. Insulet reported on Nov. 4 that U.S. Omnipod revenue reached US$570.4 million in the third quarter, up 14.7 per cent from a year earlier.
Infusion-set wear of up to seven days is already part of another listed pump maker's offering. MiniMed Group Inc. NASDAQMMED said on March 18 that its FDA-cleared Flex system supports an extended infusion set with up to seven days of wear.
The distinction for Tandem is the combination of tubeless delivery and the longer site-change interval. Its announcement concerns a new way to wear an existing pump, rather than a requirement for current eligible customers to buy new hardware.
Pharmacy Coverage Limits Initial Access
The new Mobi tubeless cartridges and infusion sets will be available exclusively through pharmacies to customers with pharmacy benefits. Tandem estimated in its Nov. 13 release that pharmacy coverage for Mobi customers was available for approximately 50 per cent of insured U.S. lives.
That estimate describes insurance coverage, rather than the number of patients using Mobi or orders for the new supplies. Tandem expects coverage to expand before launch and throughout 2027, while warning that scaling and infrastructure challenges could delay availability.
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The next commercial milestone is the planned U.S. launch in the first half of 2027. It will make the cleared tubeless supplies available to eligible customers, with pharmacy access determining who can obtain them.
