July 22, 2026 - FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot

The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center's ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model and intended to improve health outcomes for Americans managing certain chronic diseases.

"For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing," said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. "The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them."

The FDA selected Dexcom, Inc., as the first participant in the TEMPO pilot. The Dexcom Glucose Health Program, which the FDA will continue to evaluate for its intended use during the pilot, is intended to address two clinical use areas in the ACCESS Model.

The Dexcom Glucose Health Program is intended to enable patients aligned to the ACCESS model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for informed decision-making and behavioral modifications. The program is intended as an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes.

"The first TEMPO participant represents an important step toward modernizing how innovative technologies reach people with Medicare," said CMS Deputy Administrator and Director of the Innovation Center Abe Sutton. "ACCESS provides a clear payment pathway that rewards measurable improvements in patient health rather than individual services, while TEMPO helps generate the real-world evidence needed to evaluate promising new technologies responsibly."

Manufacturers participating in the TEMPO pilot will collect, monitor, and report real-world data (RWD) relating to the intended uses of their devices to improve patient outcomes, whether the device is offered by the manufacturer itself as an ACCESS participant or by another participating ACCESS organization. The TEMPO pilot will help the FDA and CMS better understand how digital health technologies perform in real-world settings and how they may support efforts to improve care for people living with chronic diseases.

The FDA plans to select up to about ten TEMPO pilot participants in each of four ACCESS model clinical use areas who reflect a broad spectrum of manufacturers and are based in the United States. The FDA also intends to select participants in alignment with the TEMPO pilot's strategic goals of promoting patient access, safeguarding patient safety, and generating meaningful RWD in connection with the ACCESS model. The FDA's considerations include, among other things, potential risks to patient health, safety, or welfare; whether there is a reasonable expectation that the device could provide patient benefit; plans for RWD collection, monitoring, analysis, and reporting; and alignment with outcomes to be measured in the ACCESS model.

The FDA, in connection with the ACCESS model, launched the TEMPO pilot to align with the rapid and iterative nature of the development of digital health devices and expand patient access to innovative technologies for specific clinical use areas while safeguarding patient safety. The ACCESS model, whose first cohort began in July 2026, aims to expand access to new technology-supported care options, such as the use of devices selected for the TEMPO pilot, to help people improve their health and prevent and manage common chronic conditions, including certain cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.

The FDA continues to consider statements of interest for participation in the pilot and intends to continue sending follow-up requests to certain potential pilot participants. There is no specified deadline for when the FDA will stop accepting statements of interest for participation in the TEMPO pilot.

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