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Participants 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. All participants selected by the FDA for the TEMPO pilot are listed in the table below.

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 participants 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.

ManufacturerDevice NameClinical Use AreaIntended Use Under Evaluation in the TEMPO PilotContraindications
SonderMind, Inc.SonderMind Adjunctive Care Application (SACA)Behavioral Health (BH)Intended to improve (reduce) levels of depression and anxiety in adult patients aged 22 years and older in treatment for moderate depression and/or anxiety, as an adjunct to treatment with psychotherapy and/or pharmacotherapy interventions, delivered via smartphone application.Contraindications include current suicidality, current manic episode, current comorbid psychosis, and current comorbid post-traumatic stress disorder (PTSD).
Limbic Inc.UnpackedBehavioral Health (BH)Intended to be used within a structured outpatient behavioral health service model to deliver evidence-based psychological treatment programs for adults who are receiving a course of psychological talking therapy via an AI-voice agent. Unpacked is indicated for use for delivering structured cognitive behavioral therapy-based treatment to Medicare beneficiaries with clinically significant depression and/or anxiety. It is intended to improve patient outcomes by increasing access to structured psychological treatment, enabling measurement-based care (MBC) and supporting clinical oversight through real-time safety flagging and outcome monitoring.Unpacked is contraindicated for individuals with suicidal or homicidal ideation, moderate to severe dementia or severe cognitive impairment, any psychiatric disorder with distinct psychotic features (such as schizophrenia, major depression with psychotic features, or bipolar I disorder), active severe self-harm without suicidal intent, complex disorders without psychotic features (such as bipolar II disorder and personality disorders), substance use disorder as a primary condition or risk of dangerous intoxication or withdrawal, eating disorders of any severity (including untreated anorexia nervosa, bulimia nervosa, and binge-eating disorder), acute physical health instability, pregnancy, frailty and advanced illness (patients aged 81 or older with a frailty indication, those receiving hospice or palliative care, or patients aged 66 or older entering long-term nursing home care during the intervention window), and individuals who are non-English speaking or reading or who lack access to a telephone.
Cadence Solutions, Inc.HypertensionOSEarly Cardio-Kidney-Metabolic (eCKM)Intended to support clinician-supervised, protocol-bound antihypertensive medication initiation and titration when predefined eligibility criteria and deterministic safety checks are satisfied. HypertensionOS  is intended for use by licensed healthcare professionals with prescriptive authority, such as physicians or Advanced Practice Registered Nurses, to assist in the outpatient management of adult patients who, at the time of initiating HypertensionOS, have diagnosed Stage 2 hypertension. Patients who progress from Stage 2 hypertension to Stage 1 hypertension while being managed with HypertensionOS may continue to be managed with HypertensionOS.N/A
Dexcom, Inc.Dexcom Glucose Health ProgramEarly 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.

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