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, Inc. (NASDAQ: TNDM) is a global insulin delivery and diabetes technology company whose news flow centers on product innovation, regulatory milestones, financial performance, and corporate developments. The company manufactures and sells advanced automated insulin delivery systems, including the Tandem Mobi system and the t:slim X2 insulin pump, both featuring Control-IQ or Control-IQ+ hybrid closed-loop technology.
News updates for Tandem Diabetes Care often highlight regulatory and product announcements. Recent examples include FDA 510(k) clearance for the SteadiSet infusion set for up to seven days of use, FDA clearance for the Android version of the Tandem Mobi mobile app, and integration of the t:slim X2 pump with Abbott’s FreeStyle Libre 3 Plus continuous glucose monitoring sensor in the United States. The company also issues press releases on software and mobile app availability, such as the Tandem t:slim mobile app launch for Android and iOS users in Canada.
Investors and observers can also expect regular earnings and guidance updates. Tandem Diabetes Care reports quarterly financial results and provides full-year guidance, with related press releases and conference call details disclosed publicly. Additional news items cover corporate governance, such as the appointment of new board members and committee assignments, as well as certifications like ISO/IEC 27001:2022 for information security.
This news page for TNDM aggregates these types of announcements, including earnings releases, regulatory clearances, product compatibility updates, conference presentations, and technology rollouts. It provides a single location to follow how Tandem Diabetes Care’s insulin delivery systems, digital platforms, and global initiatives are evolving over time.
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.
Tandem Diabetes Care (NASDAQ: TNDM) has issued a voluntary medical device correction for select t:slim X2 insulin pumps due to a critical speaker-related issue. The problem can trigger a Malfunction 16 alarm that stops insulin delivery and CGM communication, potentially leading to dangerous hyperglycemia.
The company has reported 700 confirmed adverse events and 59 reported injuries, with no deaths. Between July 22-24, 2025, affected U.S. customers received direct notifications. Tandem plans to release a software update to enhance early speaker failure detection and implement persistent vibration alerts to reduce safety risks.
Tandem Diabetes Care (NASDAQ: TNDM) reported its Q2 2025 financial results and updated full-year guidance. The company achieved record Q2 sales of $240.7 million, including $70.5 million from international markets. Q2 highlights include improved gross margins of 52% and pump shipments of 21,000 units in the U.S. and 9,000 internationally.
The company expects to reach a significant milestone of $1 billion in worldwide sales for 2025, with $700 million from U.S. sales and $300 million from international markets. However, TNDM reported a GAAP operating loss of $51.8 million (22% of sales) and adjusted its EBITDA margin guidance to negative 5% for the full year.
Notable developments include initiating an early access program for t:slim X2 with Control-IQ+ technology integrated with Abbott's FreeStyle Libre 3 Plus, receiving CE Mark for Tandem Mobi, and advancing pharmacy benefit initiatives for Q4 2025.
Tandem Diabetes Care (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, has announced its participation in three upcoming investor conferences in August and September 2025.
The company will present at the Canaccord Genuity Growth Conference on August 12 at 1:00 PM ET, the Morgan Stanley Global Healthcare Conference on September 10 at 9:15 AM ET, and will host meetings at the Bernstein Healthcare Forum on September 24. All presentations will be available via webcast on the company's investor relations website for 30 days.