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Signal Radar · SIG-2026-027

FDA TEMPO maintained participant table lists four participants

FDA's maintained TEMPO participant table currently lists four participants. FDA states that effectiveness for the participating intended uses has not yet been evaluated. The table lists SonderMind / SACA, Limbic / Unpacked, Cadence / HypertensionOS, and Dexcom / Dexcom Glucose Health Program. FDA's CDRH update log identifies the participant page as updated August 21, 2026.

Regulation + Digital HealthCurrent but high-volatility · four participants2026-08-21

Why it matters

The maintained participant table is dynamic and spans behavioral-health and cardio-kidney-metabolic use areas. Present-state surfaces should follow the maintained FDA table without treating participation as effectiveness, general approval, coverage, or endorsement.

Decision implication

For current TEMPO participation, use and timestamp the maintained FDA table. Keep TEMPO selection separate from clinical effectiveness, device-specific authorization, ACCESS participation, Medicare coverage, endorsement, and scaled adoption.

Who or what is affected

  • FDA
  • CMS Innovation Center
  • SonderMind
  • Limbic
  • Cadence Solutions
  • Dexcom
  • ACCESS organizations

Evidence and sources

Decision priority: Watch

Source authority: Primary/authoritative · official federal source

Evidence design: Program record

Applicability: Direct

Confidence for the stated claim: High

Freshness: Current

This record separates source facts from P4L interpretation. Program participation, a proposal, funding, or a public listing does not by itself establish clinical effectiveness, endorsement, coverage, or scaled adoption.

For this decision

Health-system leaders · Payers/employers · Clinicians · Policymakers · Innovators

What P4L is watching next

  • Additional TEMPO participant additions or removals
  • Changes to intended uses or contraindications
  • FDA participant-table updates
  • ACCESS implementation and participant-state changes

Related proof records

Record provenance

Last verified
2026-09-03
Source updated
2026-08-21
Revision state
Version 1.1 adds FDA's exact effectiveness limitation to the current four-participant state.
Status
Current but high-volatility · four participants
Freshness
Current
Version
1.1
Stable ID
SIG-2026-027