The FDA is building out a more structured approach to evaluating digital health devices, with participation in its TEMPO pilot expanding across companies focused on remote monitoring and behavioral health. The article describes FDA outreach that includes a third behavioral health company, Limbic, joining the pilot’s roster. TEMPO is positioned as a structured pathway for evaluating performance and safety of digital products in real-world or near-real-world conditions. The expansion builds on earlier inclusion of remote monitoring entrants like Cadence and Dexcom, signaling broader FDA engagement beyond single-company submissions. For developers, the pilot structure can influence how teams plan evidence generation, monitoring, and post-deployment evaluation—especially as more AI- and sensor-enabled products seek clear regulatory pathways.