The U.S. Food and Drug Administration cleared the Android version of Tandem’s Mobi mobile app on November 10 2025, allowing users to control the world’s smallest durable automated insulin delivery system directly from compatible Android smartphones. The approval extends Tandem’s Control‑IQ+ hybrid closed‑loop technology beyond its existing iOS‑only platform.
The clearance follows a Q3 2025 earnings report that beat expectations: revenue rose to $249.25 million versus the $235.80 million consensus estimate, and the net loss narrowed to $21.17 million from $23.25 million year‑over‑year. The earnings beat demonstrates the company’s ability to grow revenue while managing costs, a key factor that supports the strategic importance of the Android launch.
The Android app will be released in a limited rollout in December 2025, with full commercial availability slated for early 2026. It will support Google Pixel 6‑10 and Samsung Galaxy S21‑S25 models, with a full compatibility list to be published closer to launch. By opening its ecosystem to Android users, Tandem addresses a significant portion of the smartphone market that previously could not use its pump control, positioning the company against competitors that already offer multi‑platform support.
Management highlighted the launch as a milestone in Tandem’s multi‑platform strategy. CEO John Sheridan said the app “brings the convenience and discretion of the Mobi system to the devices patients already use every day.” Chief Medical Officer Dr. Jordan Pinsker added that the app “meets patients where they are, on the devices they use every day,” emphasizing the patient‑centric focus of the company’s product roadmap.
The FDA clearance also aligns with Tandem’s broader push to expand the reach of Control‑IQ+ technology, which recently received clearance for type 2 diabetes patients. The company’s Q3 2025 guidance indicated continued double‑digit growth and a target of $1 billion in worldwide sales for 2025, reflecting confidence in the expanded product portfolio and the anticipated lift from the Android launch.
Analysts noted that the earnings beat and margin improvement—gross margin rose to 54% from 51% year‑over‑year—signal effective cost control and pricing power. The company’s debt‑to‑equity ratio of 2.32 and ongoing net losses highlight the need for continued focus on profitability, but the Android launch is expected to accelerate revenue growth and broaden the addressable market.
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