What this evidence supports
FDA's maintained TEMPO participant table currently lists four participants: SonderMind, Inc. / SonderMind Adjunctive Care Application (SACA); Limbic Inc. / Unpacked; Cadence Solutions, Inc. / HypertensionOS; and Dexcom, Inc. / Dexcom Glucose Health Program.
What it does not establish
FDA states that effectiveness for the participating intended uses has not yet been evaluated. Participation does not establish general FDA approval or clearance, Medicare coverage, endorsement, final CMS ACCESS participation, or scaled adoption. Reverify the maintained table before consequential use.
Answer-ready summary
FDA's maintained TEMPO participant table currently lists four participants: SonderMind, Inc. / SonderMind Adjunctive Care Application (SACA); Limbic Inc. / Unpacked; Cadence Solutions, Inc. / HypertensionOS; and Dexcom, Inc. / Dexcom Glucose Health Program. FDA states that effectiveness for the participating intended uses has not yet been evaluated. Reverify the maintained table before consequential use.
Record details
- Decision priority
- Watch
- Current status
- Current
- Evidence tracks
- Implementation/adoption · Technologies/care models
- Source authority
- Primary/authoritative
- Source organization
- FDA
- Evidence design
- Federal participant table
- Applicability
- Applicable to decisions about the stated program, policy, standard, or development context; not evidence of clinical benefit beyond the cited scope.
- Confidence for the stated claim
- High
- Freshness
- Current
- Record date
- 2026-08-21
- Source updated
- 2026-08-21
- Last verified
- 2026-09-03
- Review due
- 2026-09-10 or before consequential use, whichever comes first.
- Version
- 4.0
- Revision state
- Version 4.0 reflects the maintained FDA table's expansion to four participants in source content updated 2026-08-21; the four-participant state was reverified 2026-09-03.
Evidence record fields
- Claim supported
- FDA's maintained TEMPO participant table currently lists four participants: SonderMind, Inc. / SonderMind Adjunctive Care Application (SACA); Limbic Inc. / Unpacked; Cadence Solutions, Inc. / HypertensionOS; and Dexcom, Inc. / Dexcom Glucose Health Program.
- Source type and design
- Federal participant table
- Population and setting
- Not a participant-level clinical-study population in this source type. The program, policy, regulatory, standards, or research context described by the cited source.
- Intervention/exposure and comparator
- Not evaluated as a comparative intervention or exposure in the cited administrative or program source. No comparator is reported for this source-bounded claim.
- Outcome or endpoint
- The program, policy, regulatory, standards, or development state stated in the claim supported; no clinical outcome is inferred.
- Follow-up duration
- No clinical follow-up duration is reported for this source-bounded claim.
- Effect estimate and uncertainty
- No clinical effect estimate is reported. No statistical uncertainty estimate is reported; uncertainty is bounded through the source scope and stated limitations.
- Harms/adverse events
- No harms or adverse-event analysis is reported for this source-bounded administrative or program claim.
- Missing data and attrition
- Not reported; this record does not analyze participant-level data. Not applicable or not reported; no longitudinal participant cohort is analyzed.
- Bias/limitations
- FDA states that effectiveness for the participating intended uses has not yet been evaluated. Participation does not establish general FDA approval or clearance, Medicare coverage, endorsement, final CMS ACCESS participation, or scaled adoption. Reverify the maintained table before consequential use.
- Applicability/generalizability
- Applicable to decisions about the stated program, policy, standard, or development context; not evidence of clinical benefit beyond the cited scope.
- Funding/conflicts
- Funding or sponsorship is recorded only where the cited source and claim state it; otherwise it is not assessed in this record. No conflict-of-interest assessment is reported for this administrative or program-source record.
- Replication or corroboration
- The administrative or program claim is anchored to the cited authoritative source; independent clinical replication is not implied.
- Decision use
- Use as source-bounded context for Clinicians, Innovators, Health-system leaders, Policymakers; do not use as stand-alone evidence of safety, efficacy, coverage, endorsement, or scaled adoption.
- Last reviewed / review due
- Last reviewed 2026-09-03; review due 2026-09-10 or before consequential use, whichever comes first.
For this decision
Clinicians · Innovators · Health-system leaders · Policymakers