Photo: Thomas M. Barwick/GettyImages
Tandem Diabetes Care, an insulin delivery and diabetes technology company, announced it received FDA clearance for the Android version of its mobile app Tandem Mobi.
The system, powered by Control-IQ Plus technology, delivers Day 1 improvements, achieving 79% time in range and 90% overnight time in range, meaning the amount of time one spends in the target blood glucose range.
Control-IQ technology decreases or stops basal insulin if readings from compatible continuous glucose monitoring sensors are predicted to be low. It also increases basal insulin if sensor readings are predicted to be high.
It can also deliver automatic correction boluses (up to one an hour) to help prevent hyperglycemia.
The mobile app aligns with Tandem's Mobi insulin pump and allows users to manage their diabetes directly from their smartphones, now including Android devices.
The company said that a limited release is expected to begin in December, with commercial availability in early 2026.
Once it is available, the Tandem Mobi Android app will be downloadable from the Google Play Store on compatible smartphones such as Google Pixel models 6 through 10 and Samsung Galaxy models S21 through S25.
"We’re excited to bring Tandem Mobi and the best-in-class outcomes of Control-IQ plus to Android users," John Sheridan, president and CEO of Tandem Mobi, said in a statement. "This latest integration gives Android users access to the life-changing benefits of Control-IQ plus, on a system that emphasizes convenience, discretion and customization.
THE LARGER TREND
On Nov. 6, Tandem Mobi reported its third-quarter 2025 financial results and reaffirmed its full-year 2025 guidance.
The company reported its worldwide sales increased to $249.3 million, which included sales outside of the U.S. of $73.6 million. Worldwide sales in Q3 of 2024 were $244 million, which included sales of $72.3 million outside the U.S.
GAAP gross profit was $134.3 million in Q3 of this year, compared to $124.7 million in Q3 of 2024. Non-GAAP gross profit was $134.3 million in Q3 2025, compared to $124.3 million in the same period last year.
GAAP operating loss was $22.9 million in the third quarter of this year, compared to $26.1 million in Q3 2024.
Non-GAAP operating loss in Q3 2025 was $22.9 million, compared to $26.5 million in the same period last year.
Third-quarter GAAP net loss this year was $21.2 million, compared to a net loss of $23.3 million in Q3 2024.
Adjusted EBITDA was $2.8 million, or 1% of sales, in the third quarter of this year, compared to $4 million, or 2% of sales, in Q3 of 2024.
The company also reported that it received FDA 510(k) clearance for extended wear use of the SteadiSet Infusion Set. In addition, it began the global commercial rollout of t:slim X2 pump integration with the FreeStyle Libre 3 Plus CGM sensor.
In October, the FDA announced a recall of Tandem Mobi's insulin pump with interoperable technology.
The product was recalled because the insulin pump, which includes a vibration motor that gives tactile feedback for any alerts, alarms or malfunctions, may exhibit false vibration motor failure due to a software issue causing "Malfunction 12."
Malfunction 12 indicates the "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active continuous glucose monitor sessions have been stopped," which could result in hyperglycemia.
The company said correction notices were mailed or emailed to customers.
In September, Tandem Diabetes Care announced that its t:slim X2 insulin pump with Control-IQ+ automated insulin delivery technology was cleared for use with Eli Lilly and Company's Lyumjev (insulin lispro-aabc injection) ultra-rapid acting insulin in the U.S.
In 2024, the t:slim X2 insulin pump, which is compatible with glucose monitoring specialist Dexcom's G7 and G6 CGM systems, was approved for sale by Health Canada.
t:slim, which holds up to 300 units of insulin, features a color touchscreen and a rechargeable battery powered via a micro-USB port, can create six customized profile settings and has the ability to integrate with multiple CGM sensors.
The HIMSS AI & Cybersecurity Virtual Forum is free to attend on Nov. 18. Learn more and register.
