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FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
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Fusion42 · 22 July 2026 · Fusion42 review
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.
◆ ◆ The Wire takeaway
If you make remote monitoring or AI-enabled chronic disease devices, the FDA just opened a fast lane to market and Medicare reimbursement simultaneously—Dexcom proved it works, and the regulator will take up to forty more companies in the next two years. The real move: you no longer need to choose between FDA approval and payer coverage; TEMPO bundles both, and there's no deadline to apply.
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1 source · 22 Jul 2026
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