FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot

The FDA has selected Dexcom as the first manufacturer in its TEMPO pilot programme, which accelerates digital health device approval and real-world evidence collection for chronic disease management technologies covered by CMS's ACCESS Model. The pilot aims to enrol up to ten participants per clinical use area, creating a faster regulatory pathway for remote monitoring and AI-enabled devices.

This Wire brief sits within Fusion42's coverage of Digital Health. Wire is Fusion42's founder-focused intelligence feed: each story is connected to the funds and startups it names — every one with a live profile on Raise or Scout — so founders can follow the capital and the momentum behind the headline rather than just the headline itself. Wire analysis is one of the live surfaces Arthur reasons over.