FDA launches pilot letting Dexcom digital glucose monitor skip premarket review

The U.S. Food and Drug Administration announced that Dexcom, a maker of continuous glucose monitors, is the first company selected for the Technology‑Enabled Meaningful Patient Outcomes (TEMPO) pilot. The program lets a narrow set of digital health devices reach patients while the agency gathers real‑world evidence, reversing the traditional pre‑market safety and effectiveness review. Dexcom will run a Glucose Health Program aimed at identifying and managing prediabetes and type 2 diabetes, and the FDA says additional manufacturers may be added.

In a related move, the FDA issued a $1.1 million funding opportunity (RFA‑FD‑26‑012) for sponsors developing digital health technologies for drug and biologic trials. The cooperative agreement supports work such as remote sensors, actigraphy, and contactless monitoring to create novel trial endpoints, compare digital and traditional measurements, and capture early signs of chronic disease. Eligible applicants include small businesses, universities, nonprofits and government entities, with the agency providing substantial involvement in the projects.