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.

Provenance

First verified

2026-08-08

Source updated

2026-08-21

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.

Last verified

2026-09-03

Status

Current but high-volatility

Freshness

Current

Version

4.0

Fingerprint

16499114a8972d0a

Change sensitivity

Very high

Evidence limits

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.

Primary source

https://www.fda.gov/medical-devices/digital-health-center-excellence/participants-selected-tempo-digital-health-devices-pilot

Related signals

• SIG-2026-001 — FDA TEMPO selects Dexcom as first participant linked to CMS ACCESS
• SIG-2026-002 — FDA TEMPO participant-table observation — August 11, 2026
• SIG-2026-027 — FDA TEMPO maintained participant table lists four participants