Tandem Diabetes Care receives FDA clearance for tubeless Mobi insulin pump
Tandem Diabetes Care announced that the U.S. Food and Drug Administration granted 510(k) clearance for its Tandem Mobi tubeless insulin delivery system. The clearance allows the infusion set to be worn for up to seven days and the cartridge for up to three days, with a full U.S. commercial launch slated for the first half of 2027. Mizuho raised its price target on the stock to $20 following the news. The company also reported Q3 2026 revenue of $283.7 million, up 13.8% year over year.
Why it matters
Mizuho’s target raise signals analyst confidence that the new product will boost sales, and the clearance opens a new revenue stream beginning in early 2027. The Q3 revenue beat and higher margin suggest strong underlying demand that could support the stock’s recent rally.
Key facts
- 1The FDA granted 510(k) clearance for the Tandem Mobi tubeless system, allowing a seven‑day infusion set and a three‑day cartridge. investing.com
- 2Tandem plans a full commercial U.S. launch in the first half of 2027. investing.com
- 3Mizuho raised its price target on TNDM from $18 to $20, maintaining a Neutral rating. investing.com
- 4Q3 2026 revenue was $283.7 million, up 13.8% year over year. investing.com
- 5Q3 2026 gross margin was 57%, up 270 basis points from the prior period. investing.com
- 6Adjusted EBITDA for Q3 2026 was $18 million, well above estimates of roughly $6.6 million. investing.com
Open questions
- Materials report different stock jump percentages: 8%, 14.2%, and ~13%.
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.