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The U.S. Food and Drug Administration (FDA) has selected Dexcom, Inc. as the first participant in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking the start of a new initiative aimed at evaluating how digital health technologies perform in real-world care settings.
Developed in partnership with the Centers for Medicare & Medicaid Services (CMS) Innovation Center, the pilot is designed to support the adoption of digital health devices while generating real-world evidence (RWE) on their impact on patient outcomes. The announcement represents an important step in aligning regulatory evaluation with value-based care for people living with chronic diseases.
The TEMPO pilot was created alongside the CMS Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model, which began enrolling its first cohort in July 2026. The ACCESS model encourages healthcare providers to improve patient outcomes through technology-supported care rather than focusing solely on individual healthcare services.
Through the pilot, participating manufacturers will collect, monitor, and report real-world data on how their digital health devices perform when used within the ACCESS model. The information will help regulators better understand whether these technologies deliver measurable improvements in patient health while maintaining safety standards.
Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health (CDRH), said the first participant marks an important milestone in testing a regulatory approach that combines patient access with real-world evidence generation.
She noted that the initiative is intended to ensure digital health technologies reach patients while providing the data needed to demonstrate meaningful clinical benefits.
Dexcom’s Glucose Health Program will be evaluated by the FDA during the pilot for its intended use within two clinical areas covered under the ACCESS model.
The digital program is designed to help patients and healthcare professionals monitor metabolic and nutritional health by combining continuous health metrics with personalized guidance, real-time data, and AI-powered insights. It is intended to support:
The FDA emphasized that the program will continue to undergo evaluation for its intended uses throughout the pilot.
CMS Deputy Administrator and Director of the Innovation Center Abe Sutton said the collaboration creates a pathway that rewards measurable improvements in patient health while enabling the responsible evaluation of emerging digital health technologies through real-world evidence.
As digital health technologies evolve rapidly, traditional regulatory pathways can struggle to capture how software-driven devices perform after they enter clinical practice. The TEMPO pilot is designed to bridge that gap by collecting evidence from routine patient care.
Rather than relying exclusively on pre-market clinical studies, manufacturers participating in the program will generate real-world data on device performance, patient outcomes, and safety while their technologies are used within the ACCESS care model.
The pilot aims to support three primary objectives:
The initiative also reflects growing collaboration between regulators and healthcare payers to evaluate technologies based on measurable health outcomes.
The FDA plans to select approximately 10 participants in each of four ACCESS model clinical use areas, representing a diverse range of U.S.-based manufacturers.
Selection will consider several factors, including:
The agency said it continues to accept statements of interest from manufacturers interested in participating in the pilot and has not announced a closing date for applications.
The ACCESS model focuses on expanding technology-supported care for chronic conditions, including selected cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
Digital health programs evaluated through TEMPO could help patients manage their conditions more effectively by providing continuous monitoring, personalized recommendations, and actionable health insights between clinical visits.
As the pilot expands, the collaboration between the FDA and CMS may help establish new evidence-generation models that support both regulatory decision-making and reimbursement for digital health technologies, while improving access to innovative care solutions for Medicare beneficiaries and other patients.
Join MedTech World Asia 2026, taking place on August 26–28, 2026, at the Hong Kong Convention and Exhibition Centre (HKCEC). Listen to industry experts speak on the panel “Digital Health & Connected Devices: Building for APAC’s Infrastructure Realities,” where they will discuss the practical challenges and opportunities shaping digital health adoption across the Asia-Pacific region. Explore the full agenda, connect with global innovators, and discover the latest developments in connected care, AI, and medical technology.
