FDA expands TEMPO pilot with new digital health partners Limbic, Cadence and Dexcom

The FDA is quietly building a pilot program called TEMPO to test a “try first, evaluate later” approach for digital health devices.

The agency has added the behavioral‑health firm Limbic to the roster, joining remote‑monitoring specialist Cadence and glucose‑monitor maker Dexcom.

The inclusion of these companies signals the FDA’s interest in gathering real‑world data across different therapeutic areas before formal regulatory decisions.

The pilot remains limited in scope, and the FDA has not disclosed timelines or criteria for moving participants toward full approval.