FDA Launches TEMPO Pilot with Dexcom to Advance Digital Health in Medicare
The FDA has initiated the TEMPO pilot program, selecting Dexcom as the inaugural manufacturer to participate. Through this pilot, digital health devices will be utilized in Medicare’s ACCESS model to gather real-world data. The joint effort with CMMI aims to enhance patient access and safety by using evidence generated from these devices to inform ...
- Published date: 09-08-2026 10:03 AM
The U.S. Food and Drug Administration (FDA) has selected Dexcom, Inc. as the first participant in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. This initiative is a collaboration between the FDA and the Center for Medicare & Medicaid Innovation (CMMI).
The pilot aims to integrate certain digital health devices into Medicare’s ACCESS model to generate real-world evidence that supports expanded patient access. By doing so, it focuses on leveraging innovative technology to improve healthcare outcomes while ensuring patient safety.
This collaboration represents a significant step toward the adoption of digital health tools within the Medicare system, highlighting a commitment to meaningful patient outcomes and evidence-based healthcare advancements.
The FDA has initiated the TEMPO pilot program, selecting Dexcom as the inaugural manufacturer to participate. Through this pilot, digital health devices will be utilized in Medicare’s ACCESS model to gather real-world data. The joint effort with CMMI aims to enhance patient access and safety by using evidence generated from these devices to inform healthcare decisions.