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Stable knowledge object · FDA TEMPO

FDA TEMPO participant status

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.

Current but high-volatilityVerified 2026-09-03

Current verified status

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 source page updated August 21, 2026.

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. Authoritative source.

What the source establishes

  • The maintained table lists SonderMind / SACA.
  • The maintained table lists Limbic / Unpacked.
  • The maintained table lists Cadence Solutions / HypertensionOS.
  • The maintained table lists Dexcom / Glucose Health Program.

What the source 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.

Prevention for Longevity (P4L) interpretation

P4L uses the maintained FDA participant table for present-state participation and keeps participant status separate from effectiveness, coverage, endorsement, and ACCESS participation.

This section is P4L interpretation, not a statement by FDA.

Related P4L records

Record maintenance

Source updated
2026-08-21
Last verified
2026-09-03
Next review due
2026-09-10
Stable URL
https://preventionforlongevity.org/signals/fda-tempo/
Shared structured source
knowledge-objects.json