The FDA recently selected the first participant for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The news release from July 22, 2026, identified Dexcom, Inc. as the first manufacturer selected for the TEMPO Pilot. Manufacturers selected for TEMPO intend to offer a device for use in providing care covered by CMS’s Innovation Center’s ACCESS model; a model intended to improve health outcomes for Americans managing certain chronic diseases such as cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.

TEMPO Pilot Selection Information

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. For participants in the pilot, the FDA intends to exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements. The FDA’s goal is to promote access to certain digital health devices while safeguarding patient safety. Participants will collect, monitor, and report real-world data relating to the intended uses of their devices to improve patient outcomes, whether the device is used by the manufacturer itself as an ACCESS participant or by another participating ACCESS organization. FDA continues to accept statements of interest for participation in the TEMPO pilot. Find details about the program at the TEMPO for Digital Health Devices Pilot homepage.

Current TEMPO Pilot Participants

The current participants in the TEMPO pilot, Dexcom, Inc. and Cadence Solutions, Inc., both have devices in the Early Cardio-Kidney-Metabolic clinical use area. The FDA anticipates that these devices will be offered to or by CMMI ACCESS participants. 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. Cadence’s device, HypertensionOS, is intended to support clinician-supervised, protocol-bound antihypertensive medication initiation and titration when predefined eligibility criteria and deterministic safety checks are satisfied.

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