Participant Selected for TEMPO for Digital Health Devices Pilot
On July 22, 2026, the FDA announced the first participant selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
Each participating manufacturer selected for TEMPO intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model and intended to improve health outcomes for Americans managing certain chronic diseases. For these manufacturers, the FDA intends to exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, when the manufacturers’ devices are offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the ACCESS model.
The TEMPO pilot is intended to promote access to certain digital health devices while safeguarding patient safety. The effectiveness of the devices selected for the pilot, for the intended uses for which they are participating in the pilot, have not yet been evaluated by the FDA. Manufacturers participating in the TEMPO pilot 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.
TEMPO Pilot Participants
The FDA has selected the following participant for the TEMPO pilot, in anticipation that the manufacturer’s device will be offered to or by CMMI ACCESS participants for the intended use listed below. The FDA intends to update this table as additional TEMPO pilot participants are selected.
| Manufacturer | Device Name | Clinical Use Area | Intended Use Under Evaluation in the TEMPO Pilot | Contraindications |
|---|---|---|---|---|
| Dexcom, Inc. | Dexcom Glucose Health Program | Early Cardio-Kidney-Metabolic (eCKM), Cardio-Kidney-Metabolic (CKM) | 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. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes. | N/A |
Selection
For information about the selection of TEMPO pilot participants, visit the TEMPO for Digital Health Devices Pilot webpage.