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Jul 22, 2026

FDA Selects Dexcom as First Participant in TEMPO Digital Health Device Pilot Program

The U.S. Food and Drug Administration announced Dexcom as the inaugural manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, which coordinates with CMS's outcomes-based ACCESS model to align device market entry and reimbursement processes.

Jul 22, 2026·5 sources
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Top claims

  • ▪Dexcom, Inc. will develop the Dexcom Glucose Health Program, an AI-driven initiative integrating data from its Dexcom G7 and Stelo devices with contextual health factors like nutrition, exercise, sleep, and stress.
  • ▪The CMS Innovation Center's ACCESS model, which began its first cohort in July 2026, establishes a payment pathway that rewards measurable improvements in patient health rather than individual services.
  • ▪FDA selection criteria for the TEMPO pilot include potential patient health risks, reasonable expectation of benefit, RWD collection plans, and alignment with ACCESS model outcomes.

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