# FDA Launches TEMPO Digital Health Pilot with CMS to Expand Access to Chronic Disease Technologies

> news · REPORTED · 2025-07-10

The FDA launched the TEMPO pilot in collaboration with the CMS Innovation Center's ACCESS model, enabling participating manufacturers of certain digital health devices to offer products for chronic disease care while collecting real-world performance data. The pilot is designed to help FDA and CMS better understand how digital health technologies perform in real-life settings.

About FDA / CMS: The FDA's TEMPO pilot is a regulatory and coverage initiative co-developed with CMS to accelerate access to digital health technologies for patients living with chronic diseases while generating real-world evidence.

- Company: FDA / CMS
- Sector: digital health
- Primary source: https://www.fda.gov/news-events/press-announcements/fda-launches-tempo-first-its-kind-digital-health-pilot-expand-access-chronic-disease-technologies

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.