Tandem Diabetes Care, Inc.

Tandem Mobi Automated Insulin Delivery System Now Available in Twelve International Markets

Tandem Diabetes Care announced that its Tandem Mobi automated insulin delivery system is now available in 12 countries outside the United States, with orders open and shipping in markets including Germany, the UK, Italy, Spain, Israel, and Switzerland. The pocket-sized durable pump runs Control-IQ+ technology paired with the Dexcom G7 CGM, predicting glucose 30 minutes ahead and adjusting insulin every 5 minutes, with iPhone app control and a 200-unit cartridge. The company flagged Android compatibility and Abbott sensor integrations expected to launch in select countries in 2027, and no revenue or unit-shipment figures were disclosed with the expansion.

•27d ago

Tandem Diabetes Care Announces Second Quarter 2026 Financial Results

Tandem Diabetes Care reported Q2 revenue of $254.6 million, up 6% year-over-year, with gross margin expanding 460 basis points to 57%. Operational efficiency improved significantly, reducing the GAAP operating loss to $13.8 million and delivering positive Adjusted EBITDA of $6.4 million. The company reaffirmed full-year sales guidance of $1.065 billion to $1.085 billion and lowered its non-cash charge guidance to $85 million. Strategic highlights include the 510(k) submission for Tandem Mobi tubeless capability and FDA clearance for Control-IQ+ use during pregnancy and for Type 2 diabetes.

•2mo ago

Tandem Diabetes Care Launches t:slim X2 Insulin Pump Compatibility with Abbott FreeStyle Libre 3 Plus Sensor in Five International Markets

Tandem Diabetes Care announced that its t:slim X2 insulin pump with Control-IQ+ technology is now compatible with Abbott’s FreeStyle Libre 3 Plus sensor in the UK, Switzerland, Sweden, Finland, and Italy. The company plans to expand this compatibility to additional markets including Belgium, the Netherlands, and Germany later in 2026, providing more CGM options for international users. The Libre 3 Plus sensor can be worn for up to 15 days and transmits glucose data every minute, enabling the Control-IQ+ algorithm to adjust insulin delivery every five minutes.

•3mo ago

Tandem Diabetes Care Automated Insulin Delivery Systems Receive CE Mark for Type 2 Diabetes and Type 1 Diabetes During Pregnancy

Tandem Diabetes Care received CE Mark approval in Europe for its t:slim X2 and Tandem Mobi systems for use in Type 2 Diabetes and Type 1 Diabetes during pregnancy. The Type 1 pregnancy indication is supported by the CIRCUIT trial published in JAMA, which showed 12.6% more time in range (approx. 3 hours/day) compared to standard therapy. The Type 2 indication is backed by the 2IQP trial published in NEJM, demonstrating a 0.9% A1C reduction overall and 2.3% for patients with baseline A1C >=9%, with no new safety signals.

•4mo ago

Tandem Diabetes Care Announces First Quarter 2026 Financial Results

Tandem Diabetes Care delivered Q1 sales of $247.2 million, up 5% year-over-year, while achieving record pump shipments and expanding gross margin to 55%. The company reported positive Adjusted EBITDA of $2.7 million, a significant improvement from a loss of $79.9 million in the prior year, driven by operational efficiency and a 0.00% convertible debt offering. Management reaffirmed full-year 2026 guidance for sales between $1.065 billion and $1.085 billion, with Adjusted EBITDA margin expected to reach 5% to 6%.

•5mo ago

Tandem Diabetes Care’s Control-IQ+ Automated Insulin Delivery Technology Now FDA Cleared for Pregnancy in Type 1 Diabetes

The FDA cleared Tandem Diabetes Care's Control-IQ+ technology for use in pregnancy with type 1 diabetes, marking the first and only automated insulin delivery system approved for this population in the U.S. The clearance was supported by the CIRCUIT trial, which demonstrated a 12.6% improvement in time in the pregnancy-specific glucose range compared to standard therapy. This label expansion applies to both the t:slim X2 and Tandem Mobi systems, effectively strengthening the company's competitive positioning in the diabetes management market.

•5mo ago