On July 22, 2026, the U.S. Food and Drug Administration (FDA) announced the selection of the first participant in the TEMPO pilot program, an acronym for Technology-Enabled Meaningful Patient Outcomes, which is dedicated to digital health devices. The currently published list includes three manufacturers and their devices, with the agency confirming that it will update the list when additional participants are selected.
The program focuses on devices expected to be used in delivering care covered by the ACCESS model of the Center for Medicare and Medicaid Innovation (CMMI). The model aims to help Americans managing certain chronic conditions through technologies intended to contribute to improved health outcomes.
What Does the Program Offer Companies?
For participating companies, the FDA intends to exercise what is known as enforcement discretion regarding certain regulatory requirements, such as premarket authorization for the device and requirements for devices used in investigations, when the devices are offered to or through participants in the ACCESS model and for the intended use associated with improving patient outcomes and delivering care expected to be covered under the model.
Inclusion in TEMPO does not mean that the FDA has approved the effectiveness of any device for the specific use covered by the program. The effectiveness of participating devices for these uses has not yet been evaluated by the agency. In contrast, manufacturers must collect, monitor, and report real-world data, whether the device is used by the company itself in its capacity as an ACCESS participant or by another organization participating in the model.
Devices and Clinical Areas
- Limbic Inc. – Unpacked: Falls within the behavioral health area and is used within a structured model for outpatient behavioral health services to provide evidence-based psychotherapy programs to adults receiving talk therapy through an AI-powered voice agent. The program aims to provide structured cognitive behavioral therapy for Medicare beneficiaries with clinically significant depression or anxiety, while supporting measurement-based care and clinical supervision through immediate safety alerts and outcome monitoring. Contraindications include conditions such as suicidal or homicidal ideation, moderate to severe dementia, disorders with psychotic features, certain complex disorders, substance use disorders as a primary condition, eating disorders, acute physical instability, pregnancy, and frailty or advanced illness. It is also not intended for people who do not speak or read English or who do not have a phone.
- Cadence Solutions, Inc. – HypertensionOS: Falls within the early cardio-kidney-metabolic area and supports the initiation and dose adjustment of hypertension medications according to protocols and under the supervision of licensed health practitioners with prescribing authority. It is used for adults with stage 2 hypertension at the time of system initiation, with continued management possible if the patient moves to stage 1 during follow-up. The list did not identify any contraindications for this device.
- Dexcom, Inc. – Dexcom Glucose Health Program: Covers the early cardio-kidney-metabolic and broader cardio-kidney-metabolic areas. It enables patients compatible with the ACCESS model and care professionals or providers to monitor metabolic and nutritional status, receive personalized guidance, and access real-time data and AI-supported insights for informed decision-making and behavior modification. It is also used to help screen for prediabetes and type 2 diabetes through integrated digital health indicators and may contribute to improved blood glucose control and reduced HbA1c in people with prediabetes.
Why Does This Selection Matter?
TEMPO places digital devices in a pilot pathway that combines facilitated access to technologies targeting chronic diseases with continued monitoring of safety and outcomes. In practice, device selection does not constitute advance certification of its effectiveness; rather, it links the intended use to the collection of evidence from real-world practice and its submission to the FDA, making the resulting data an essential part of evaluating the pilot during its later stages.