Tandem Diabetes Stock Price, News & Analysis
Company Description
Tandem Diabetes Care, Inc. (NASDAQ: TNDM) is a global insulin delivery and diabetes technology company that focuses on advanced automated insulin delivery systems. According to the company’s public disclosures, Tandem Diabetes Care designs, manufactures, and sells durable insulin pumps and related technologies intended to reduce the burden of diabetes management for people who require insulin therapy. The company’s common stock is listed on the NASDAQ Global Market under the symbol TNDM.
Tandem Diabetes Care is based in San Diego, California. In its descriptions in press releases and SEC filings, the company emphasizes that it serves individuals living with diabetes, as well as their caregivers and healthcare providers, by providing insulin delivery systems and connected digital tools that support therapy management.
Core business and products
The firm’s business centers on automated insulin delivery (AID) systems and related accessories. Tandem Diabetes Care’s pump portfolio, as described in multiple company press releases, includes:
- Tandem Mobi system, described as a durable automated insulin delivery system powered by Control-IQ+ technology.
- t:slim X2 insulin pump, a durable insulin pump that also features Control-IQ or Control-IQ+ advanced hybrid closed-loop technology.
According to the Polygon description and company communications, Tandem Diabetes Care designs, manufactures, and markets durable insulin pumps for individuals with diabetes and has introduced multiple generations of pumps since entering the market. The Polygon data further notes that the company generates a meaningful portion of its sales from insulin pumps and from disposable infusion sets used with those pumps.
Company disclosures also reference SteadiSet, a wearable infusion set that delivers insulin from an insulin pump to the body and is designed for extended wear. According to an 8-K filing, SteadiSet is intended for use with the t:slim X2 and Tandem Mobi pumps and for future tubeless insulin delivery systems.
Diabetes technology and connected care
Tandem Diabetes Care describes itself as a diabetes technology company, reflecting its focus on integrating insulin pumps with software, mobile applications, and cloud-based platforms. The company highlights several key technology components in its public materials:
- Control-IQ and Control-IQ+ technology, described as advanced hybrid closed-loop algorithms that automatically adjust insulin delivery based on continuous glucose monitoring (CGM) data and predicted glucose values. Company press releases state that Control-IQ+ can increase, decrease, or suspend basal insulin and deliver correction boluses when glucose is predicted to exceed certain thresholds, within indicated age and insulin-use parameters.
- Tandem t:slim mobile app, a secure mobile application that, when paired with a t:slim X2 insulin pump, can display pump information on a compatible smartphone, allow delivery and cancellation of a bolus from the phone, show recent glucose trends and insulin therapy data, and upload data to the cloud-based Tandem Source platform. The app is described as an accessory that communicates reliably and securely with compatible pumps.
- Tandem Mobi mobile app, a mobile application designed to pair with the Tandem Mobi insulin pump so users can manage aspects of their therapy from a compatible smartphone. Company communications emphasize its secure connectivity and integration with the Tandem Source platform.
- Tandem Source platform, a cloud-based platform intended for individuals using Tandem insulin pumps, their caregivers, and healthcare providers. It supports diabetes management through display and analysis of information uploaded from Tandem pumps.
Public statements also note integrations with continuous glucose monitoring systems, such as the FreeStyle Libre 3 Plus CGM sensor, which can transmit automatic glucose readings directly to the t:slim X2 pump. Tandem’s communications describe this integration as part of a global commercial rollout aimed at expanding choice and personalization for people living with diabetes.
Regulatory clearances and indications
Company press releases and SEC filings highlight several regulatory milestones and indications:
- The Tandem Mobi insulin pump with interoperable technology and Control-IQ+ is indicated for subcutaneous delivery of insulin for the management of diabetes mellitus in persons requiring insulin, with specified minimum age and insulin-use requirements.
- The t:slim X2 insulin pump with interoperable technology and Control-IQ+ is indicated for persons with diabetes who require insulin, with age indications for type 1 and type 2 diabetes described in the company’s safety information.
- The company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the SteadiSet infusion set for up to seven days of use, as disclosed in an 8-K filing.
- Tandem Diabetes Care has announced FDA clearance for the Android version of the Tandem Mobi mobile app, expanding its availability on compatible Android smartphones.
- The t:slim X2 insulin pump with Control-IQ+ technology has been cleared in the United States for use with certain U-100 insulins, including Lyumjev, based on clinical data described in company communications.
These regulatory clearances are central to the company’s ability to market its insulin delivery systems and accessories in the United States and other regulated markets.
Geographic reach and markets
Company press releases describe Tandem Diabetes Care as a global insulin delivery and diabetes technology company. The Polygon description notes that a significant portion of the company’s revenue is derived from the United States, with the remainder primarily from other developed nations. Public announcements reference commercial activities and product availability in multiple regions, including the United States and Canada, and plans for broader international rollout of integrated technologies.
Examples from recent communications include the availability of the Tandem t:slim mobile app for Android and iOS users in Canada and plans for early-access programs and commercial scaling of t:slim X2 and FreeStyle Libre 3 Plus integration in additional countries.
Information security and certifications
Tandem Diabetes Care has publicly announced that it achieved ISO/IEC 27001:2022 certification, an international standard for Information Security Management Systems (ISMS). According to the company, this certification followed an independent audit of its information security practices, including physical security systems, vendor access controls, employee training, and data management processes. The company states that this certification supports its operations in regulated markets and simplifies compliance for partners and healthcare providers.
Corporate governance and stock information
SEC filings confirm that Tandem Diabetes Care, Inc. is a public company with common stock registered under Section 12(b) of the Securities Exchange Act of 1934 and traded on the NASDAQ Global Market under the symbol TNDM. Filings also document actions of the board of directors, such as the appointment of additional independent directors and committee assignments, reflecting the company’s governance structure.
The company files periodic reports, current reports on Form 8-K, and other documents with the U.S. Securities and Exchange Commission, which provide detailed information on its operations, financial condition, and material events.
Revenue sources and business model
According to the Polygon description, Tandem Diabetes Care generates revenue from the sale of durable insulin pumps and from disposable infusion sets that must be replaced regularly. The Polygon data indicates that the pumps themselves account for a substantial portion of total sales, with infusion sets contributing a significant additional share. Company press releases also reference multi-channel initiatives, including pharmacy benefit coverage for Tandem Mobi and t:slim X2 supplies, which relate to how products reach customers and are reimbursed.
Overall, the company positions its business model around insulin delivery hardware, associated disposables, and connected digital health tools that support ongoing diabetes management.