FDA Names Dexcom First Participant in TEMPO, Its Outcome-Linked Digital Health Pilot With CMS
The joint FDA-CMS pilot ties regulatory evaluation to real-world outcomes and Medicare coverage — and Dexcom's AI-driven Glucose Health Program is the template case.
The FDA has selected Dexcom as the first manufacturer for its TEMPO pilot — Technology-Enabled Meaningful Patient Outcomes — a joint initiative with the CMS Innovation Center that supports the ACCESS Model for chronic disease management.
Dexcom was chosen for its Glucose Health Program, an AI-driven metabolic monitoring offering spanning prediabetes and type 2 diabetes screening and glycemic control. The FDA plans to select up to roughly ten TEMPO participants in each of the ACCESS Model's four clinical use areas; the model's first cohort launched in July 2026.
CDRH Director Michelle Tarver framed the pilot as getting "the right technology at the right time" to millions of Americans with chronic conditions.
Why TEMPO is a big deal
TEMPO operationalizes something digital health has requested for a decade: coordination between the agency that clears a technology and the agency that pays for it. By using real-world outcome data to link regulatory evaluation with Medicare coverage, the pilot rewards measurable health improvement rather than per-service billing volume.
For device and digital therapeutic makers, Dexcom's selection creates a template to study closely: a coverage-with-evidence pathway where the data generated in deployment does double duty — informing the FDA's view of the product and CMS's willingness to pay for it. If TEMPO scales, it could become the standard route to market for outcome-driven digital health.
Reporting: FDA press announcement, July 22, 2026.
Source
Original reporting: FDA ↗