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Dexcom is first to join FDA/CMS health tech pilot
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The FDA has named Dexcom as the first medical device manufacturer that will take part in a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to patients more quickly.
First announced last December as part of a deregulatory drive under former FDA Commissioner Marty Makary, the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot will assess the Dexcom Glucose Health Programme, an AI-powered system that integrates real-time glucose biosensor data with lifestyle factors like diet, sleep, and physical activity.
Aimed at people with type 2 diabetes and prediabetes, the platform combines a continuous glucose monitor device, which sends readings to a smartphone every few minutes, with software that provides glucose data and alerts for patients and their healthcare providers.
"ACCESS provides a clear payment pathway that rewards measurable improvements in patient health rather than individual services, while TEMPO helps generate the real-world evidence needed to evaluate promising new technologies responsibly," he added.
"Glucose is one of the body's most powerful health signals, providing immediate insight into a person's overall health," according to Jake Leach, president and chief executive of Dexcom, who said that participating in the pilot "marks another first for Dexcom and underscores our continued leadership in innovation."