Welcome to our dedicated page for Tandem Diabetes news (Ticker: TNDM), a resource for investors and traders seeking the latest updates and insights on Tandem Diabetes stock.
Tandem Diabetes Care (TNDM) delivers innovative insulin management solutions through advanced pump technology and connected diabetes care platforms. This news hub provides investors and healthcare professionals with timely updates on corporate developments, product milestones, and regulatory progress.
Access official press releases covering quarterly financial results, new product clearances, and strategic partnerships alongside analysis of market trends impacting diabetes care technology. Our curated collection ensures you stay informed about pump software updates, clinical trial outcomes, and international expansion efforts.
Key updates include FDA submissions, insulin delivery system enhancements, and operational developments across global markets. Bookmark this page for direct access to Tandem Diabetes' latest announcements, including pump compatibility improvements and user experience initiatives that shape modern diabetes management.
Tandem Diabetes Care (Nasdaq: TNDM) announced the appointment of Sandra Beaver to its board of directors effective November 7, 2025. Ms. Beaver joins as an independent director and will serve on the board’s Audit Committee and Cybersecurity and Data Oversight Committee. She brings more than 20 years of strategic and operational finance experience across healthcare, medical devices, enterprise technology, gaming and manufacturing. Ms. Beaver is currently CFO at Lyra Health (since June 2025) and previously served three years as CFO at Evolus, with prior senior finance roles at Experian and IGT. Her credentials include a Bachelor of Business Administration from University of Massachusetts and a Professional Designation in Relational Database Design from UCLA.
Tandem Diabetes Care (Nasdaq: TNDM) announced FDA clearance of the Android version of the Tandem Mobi mobile app, expanding compatibility to Android smartphones and extending its connected-care ecosystem.
Key facts: the app pairs with the Tandem Mobi automated insulin delivery system powered by Control-IQ+, cites outcomes including 79% time in range and 90% overnight time in range, and will begin a limited release in December 2025 with commercial availability in early 2026. Compatible devices slated to include Google Pixel 6–10 and Samsung Galaxy S21–S25; a full compatibility list will be published before launch.
Tandem Diabetes Care (Nasdaq: TNDM) reported Q3 2025 results on November 6, 2025, and reaffirmed full‑year 2025 guidance.
Key metrics: Q3 sales $249.3M worldwide with $73.6M outside the U.S.; U.S. shipments >20,000 pumps and international shipments >9,000 pumps. GAAP gross profit was $134.3M and GAAP gross margin improved to 54% from 51% year‑over‑year. GAAP net loss was $21.2M; GAAP operating loss was $22.9M (‑9% of sales). Adjusted EBITDA was $2.8M (1% of sales).
Operational progress: expanded pharmacy coverage for Tandem Mobi to >40% of U.S. lives, introduced t:slim X2 supplies via pharmacy, received FDA 510(k) for SteadiSet extended wear, filed 510(k) for Android control of Tandem Mobi, and began global rollout of t:slim X2 with FreeStyle Libre 3 Plus CGM.
Full‑year 2025 guidance: ~$1.0B sales (U.S. ~ $700M; non‑U.S. ~ $300M), gross margin ~53%–54%, and adjusted EBITDA margin ~‑5% (guidance recast to include an IPR&D charge).
Tandem Diabetes Care (Nasdaq: TNDM) announced on November 4, 2025 that it achieved ISO/IEC 27001:2022 certification from Insight Assurance, confirming a company-wide Information Security Management System (ISMS).
The certification follows a comprehensive independent audit of physical security, vendor access controls, employee training, and data management practices and is presented as strengthening Tandem’s position in regulated international markets while simplifying compliance for partners and healthcare providers.
Company leadership framed the achievement as evidence of commitment to cybersecurity, data protection, and operational integrity and provided links for multimedia and further cybersecurity information.
Tandem Diabetes Care (NASDAQ:TNDM) will present company updates at two investor conferences: the Stifel 2025 Healthcare Conference on Tuesday, November 11, 2025 at 10:40 AM ET (7:40 AM PT), and the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:30 AM ET (7:30 AM PT).
Both presentations will be webcast live, and an archive recording will be available for 30 days. Live and archived webcasts will be accessible in the company’s Investor Center under Events & Presentations at http://investor.tandemdiabetes.com.
Tandem Diabetes Care (NASDAQ: TNDM) announced that the t:slim X2 insulin pump with Control-IQ+ automated insulin delivery is now available in the United States with integration for Abbott’s FreeStyle Libre 3 Plus CGM sensor.
The updated software is preloaded on all new U.S. t:slim X2 shipments and offered as a free remote software update to eligible existing users. Tandem plans early-access international launches before year-end 2025 and scaled commercial availability in 2026.
Key device facts: the FreeStyle Libre 3 Plus transmits glucose readings every 1 minute and offers 15-day wear; Control-IQ+ adjusts insulin every 5 minutes and includes AutoBolus to automatically calculate and deliver correction boluses.
Tandem Diabetes Care (Nasdaq: TNDM) will release its third quarter 2025 financial and operating results after market close on Thursday, November 6, 2025.
The company will host a live conference call and webcast the same day at 4:30 PM ET (1:30 PM PT). The webcast will be available at http://investor.tandemdiabetes.com in the “Events & Presentations” section. Participants can join the call by phone via the registration link provided in the press release to receive dial-in details and a personal PIN.
An archived webcast will be available for 30 days after the event on the company’s Investor Center site.
Tandem Diabetes Care (NASDAQ: TNDM) announced that its t:slim X2 insulin pump with Control-IQ+ automated insulin delivery technology has received clearance for use with Lyumjev ultra-rapid acting insulin in the United States. The approval applies to people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes.
The clearance was supported by a 13-week multicenter study involving 179 individuals, demonstrating high satisfaction and quality of life benefits. The t:slim X2 pump is now compatible with three insulin types: Humalog, Novolog, and Lyumjev U-100. Notably, Lyumjev is accessible through Lilly's Insulin Value Program at $35 monthly for those with commercial insurance or no insurance.
Tandem Diabetes Care (NASDAQ: TNDM) announced a significant study publication in Diabetes Care showing that their Control-IQ+ automated insulin delivery (AID) system benefits adults with type 2 diabetes regardless of their C-peptide levels. The sub-analysis of the 2IQP trial, involving 254 participants, demonstrated that patients using the t:slim X2 insulin pump with Control-IQ+ technology experienced a mean HbA1c decrease of 0.8% from baseline, significantly outperforming the control group.
The study challenges current Center for Medicare and Medicaid Services (CMS) criteria, which requires low C-peptide levels for insulin pump coverage. The research found equal benefits in both high C-peptide (N=195) and low C-peptide (N=59) groups, suggesting that C-peptide thresholds should not restrict access to AID therapy.
Tandem Diabetes Care (NASDAQ: TNDM) has received Health Canada authorization for its t:slim mobile application for both Android and iPhone platforms. The app enables users to deliver insulin boluses from their smartphones and upload pump data to the cloud-based Tandem Source platform.
The mobile app, expected to launch later in 2025, will display 24-hour glucose trends, pump status changes, insulin therapy data, and alerts when paired with a t:slim X2 insulin pump. Importantly, the t:slim X2 insulin pump operates independently from the app, ensuring users can always manage their therapy directly from the pump.
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