Tandem Diabetes Care reports developments in automated insulin delivery and diabetes technology. The company manufactures and sells pump systems including Tandem Mobi and the t:slim X2 insulin pump, both powered by Control-IQ+ advanced hybrid closed-loop technology. News commonly covers FDA clearances, pump and mobile-app compatibility, continuous glucose monitoring integrations, and product portfolio updates for people with diabetes.
Company updates also address quarterly and annual operating results, worldwide and U.S. sales trends, pump shipments, gross margin, financial guidance, reimbursement-model changes, investor conference presentations, and capital actions such as convertible debt financing.
Tandem Diabetes Care (Nasdaq: TNDM) received FDA clearance for a tubeless Tandem Mobi automated insulin delivery system using new accessories. The new infusion set is cleared for up to 7 days of wear, while the cartridge is cleared for 3 days of use. The pump now supports both tubed and tubeless insulin delivery with Control-IQ+ technology, which automatically adjusts insulin delivery.
Tandem plans a full U.S. commercial launch in the first half of 2027. Existing Tandem Mobi pumps are compatible; customers with an in-warranty pump will not need a replacement. The tubeless sets and cartridges will be available exclusively through pharmacies for customers with pharmacy benefits. Tandem estimates pharmacy coverage for Mobi customers reaches approximately 50% of insured lives in the United States and expects coverage to expand ahead of launch and throughout 2027.
Tandem Diabetes Care (Nasdaq: TNDM) received Health Canada approval expanding compatibility and indications for its t:slim X2 insulin pump.
The amendment covers Abbott’s FreeStyle Libre 3 Plus sensor, adults with type 2 diabetes and pregnancy in type 1 diabetes. Tandem expects availability in the second quarter of 2027. Pregnancy use requires a linked continuous glucose monitor suitable for pregnancy.
In CIRCUIT, Control-IQ users spent 12.6% more time in the pregnancy glucose target range than standard-therapy users, approximately 3 hours daily, from 16 weeks gestation through pregnancy’s end. In the 2IQP trial, Control-IQ+ users achieved a 0.9% A1C reduction, versus 0.3% for controls; users starting at 9% or higher achieved a 2.3% reduction. A1C measures longer-term blood sugar. The trial reported low rates of low blood sugar, no new safety signals and no diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome events.
Tandem Diabetes Care (Nasdaq: TNDM) appointed Jeannette Bankes president and chief executive officer, effective November 16, 2026. Bankes will also join the Board of Directors, succeeding John Sheridan as part of a planned leadership transition. Sheridan will remain an employee through the end of 2026, then serve as a consultant to support the transition. The appointment follows a Board-led succession and search process.
The Board also approved an inducement award of restricted stock units, representing rights to receive shares, valued as close as practicable to, but not exceeding, $10,000,000. The grant takes effect December 15, 2026. One-third will vest on the first anniversary, with the remaining two-thirds vesting in eight equal quarterly installments. The award will be granted outside Tandem’s 2023 Long-Term Incentive Plan but subject to its terms.
Tandem Diabetes Care (TNDM) reported third-quarter 2026 sales of $283.7 million, with growth across its U.S. and international businesses. Worldwide sales rose 14% year over year. U.S. sales increased 9% to $191.0 million, while international sales rose 26% to $92.6 million. Gross margin reached 57%, compared with 54% a year earlier.
Operating loss narrowed to $2.4 million from $22.9 million, and net loss narrowed to $7.1 million from $21.2 million. Adjusted EBITDA, a non-GAAP earnings measure, increased to $18.0 million from $2.8 million. U.S. pump shipments were nearly 23,000, compared with more than 20,000.
The company reaffirmed 2026 sales guidance of approximately $1.065 billion to $1.085 billion, gross margin of approximately 56% to 57%, and adjusted EBITDA margin of approximately 5% to 6%. Cash, cash equivalents and short-term investments reached $443.082 million at September 30.
Tandem Diabetes Care (Nasdaq: TNDM) management will present company updates at investor conferences on November 19 and December 3, 2026.
The Jefferies Global Healthcare Conference presentation begins at 8:00am Greenwich Mean Time on November 19. The Piper Sandler 38th Annual Healthcare Conference presentation begins at 9:00am Eastern Time on December 3. Live webcasts and recordings available for 30 days will be accessible through the company’s Investor Center.
Tandem Diabetes Care (TNDM) plans to release its third quarter 2026 financial results after markets close on November 5, 2026.
A conference call and simultaneous webcast will discuss financial and operating results at 4:30 pm Eastern Time (1:30 pm Pacific Time) that day. The webcast will be available through the company’s Investor Center, with an archive available for 30 days following the event.
Tandem Diabetes Care (TNDM) is taking orders and shipping its Tandem Mobi insulin delivery system to eligible customers in 12 countries. The markets are Belgium, the Czech Republic, Denmark, Finland, Germany, Israel, Italy, Luxembourg, Spain, Sweden, Switzerland and the United Kingdom.
Mobi pairs Control-IQ+ technology with a Dexcom G7 glucose sensor to predict glucose levels 30 minutes ahead and adjust insulin delivery every 5 minutes. It has a 200-unit cartridge and can be worn on the body, clipped to clothing or carried in a pocket. Mobile control requires a compatible iPhone. Studies of Control-IQ+ in people with type 1 or type 2 diabetes, including type 1 diabetes during pregnancy, reported improvements in glucose control. Tandem expects Android compatibility and the start of Abbott sensor integration launches in select countries in 2027.
Tandem Diabetes Care (Nasdaq: TNDM) reported second quarter 2026 sales of $254.6 million, up 6% year over year, with U.S. sales of $179.3 million and international sales of $75.3 million. Pump shipments exceeded 33,000 units worldwide, including more than 22,000 in the U.S.
Gross profit was $144.8 million with a 57% gross margin, up 460 basis points. GAAP and non-GAAP operating loss narrowed to $13.8 million (−5% margin), and GAAP and non-GAAP net loss was $21.2 million. Adjusted EBITDA was $6.4 million (3% margin), versus negative $1.8 million a year ago. Cash, cash equivalents and short-term investments were $456.0 million at June 30, 2026.
The company reaffirmed 2026 sales guidance of $1.065–$1.085 billion, gross margin of 56–57%, and adjusted EBITDA margin of 5–6%. It lowered expected 2026 non-cash charges to $85 million from $100 million. Strategic milestones included an FDA 510(k) submission for Tandem Mobi tubeless capability, new Control-IQ+ indications, expanded Dexcom G7 and Abbott FreeStyle Libre 3 Plus sensor compatibility, and the international commercial rollout of Tandem Mobi.
Tandem Diabetes Care (Nasdaq: TNDM) announced that management will present a company update at Canaccord Genuity’s 46th Annual Growth Conference on Tuesday, August 11, 2026, at 1:30pm Eastern / 10:30am Pacific. The presentation will be webcast live, with a 30-day archive available via the company’s Investor Center website in the “Events & Presentations” section.
Tandem Diabetes Care (NASDAQ:TNDM) launched compatibility between its t:slim X2 insulin pump with Control-IQ+ automated insulin delivery and Abbott’s FreeStyle Libre 3 Plus CGM sensor in the UK, Switzerland, Sweden, Finland, and Italy.
The sensor provides 15-day wear, 1-minute glucose updates, mobile app visibility, and supports Tandem’s AutoBolus feature. Additional launches are expected in 2026, including Belgium, the Netherlands, and Germany.