Tandem Expects FDA Approval for Mobi Tubeless Capability in Fourth Quarter of 2026
Key Facts
Tandem Diabetes Care said it expects the U.S. Food and Drug Administration to approve the Mobi system's ability to operate without tubing in the fourth quarter of 2026, according to CEO John Sheridan on the company's earnings call on November 6. The company submitted a 510(k) regulatory review application to the agency in the second quarter of the year. The expected timing is the latest disclosed review timeframe, not an announcement that approval has been granted. On the call, Sheridan said, "We expect it to be approved in the fourth quarter." The available information did not include subsequent confirmation that approval had been granted as of November 12, the date attributed to the circulating report.
The company set the initial filing's scope for use on the abdomen, Sheridan said on the call. He said Tandem later aims to add other device-wear locations and other types of insulin. This means the announced regulatory expectation relates to the initial application as submitted, while the expansions mentioned by the CEO remain later efforts. He did not specify a timeline for those additions. The expectation of approval does not establish that authorization has been granted or that the product has become commercially available in its tubeless form.
The regulatory expectations came as Tandem's business grew in the third quarter of 2026. Global sales were $283.7 million, compared with $249.3 million in the third quarter of 2025, an annual increase of 14%, according to the company's results. In the U.S., sales rose 9% to $191.0 million from $175.6 million in the year-earlier period. International sales increased 26% to $92.6 million from $73.6 million a year earlier. The company said international sales growth was 27% on a constant-currency basis.
The results showed gross margin improving to 57% in the third quarter from 54% in the same period a year earlier. Operating loss also narrowed to $2.4 million, compared with an operating loss of $22.9 million in the third quarter of 2025, the company said. The operating loss in the latest period was equivalent to 1% of sales, versus 9% in the comparable period. These figures place the company's operating performance in the context of its announcement about the Mobi tubeless review process. They relate to the third quarter and are not an independent estimate of the impact of any future approval on results.
Mobi was available in 12 countries by the time the company announced on November 5, while U.S. pharmacy-list coverage reached about 50% of the population. Tandem also said about 15% of its U.S. sales in the third quarter went through the pharmacy channel, as it expanded its pay-as-you-go model. These indicators provide commercial context for developments in the Mobi system, but describe the system's availability, list coverage and sales channel as reported at the time. They do not in themselves mean that the tubeless version covered by the review application became available through that channel. The company did not specify a commercial launch date for the new capability in the information provided.
Tandem shipped about 33,000 pumps worldwide in the third quarter of 2026, including about 23,000 pumps in the U.S., according to results released on November 5. The shipment volume provides a measure of the existing pump business during the period, alongside the sales growth reported in the results. On August 6, 2025, the company reported receiving 510(k) clearance for SteadiSet technology for use for up to seven days. It said at the time that it also planned to use the technology in a future tubeless Mobi system. That clearance concerns SteadiSet infusion-set technology, while the tubeless Mobi application submitted in the second quarter of 2026 remains a separate regulatory filing in the available information.