--- title: FDA picks Dexcom for TEMPO pilot, skipping premarket review description: The FDA has selected Dexcom as the first participant in its TEMPO pilot program, which allows digital health devices to reach Medicare patients before... canonical: https://daily.dev/posts/fda-picks-dexcom-for-tempo-pilot-skipping-premarket-review-vz2up8avf twitter:card: summary_large_image twitter:site: @dailydotdev og:type: website og:site_name: daily.dev og:title: FDA picks Dexcom for TEMPO pilot, skipping premarket review | daily.dev og:description: The FDA has selected Dexcom as the first participant in its TEMPO pilot program, which allows digital health devices to reach Medicare patients before... og:url: https://daily.dev/posts/fda-picks-dexcom-for-tempo-pilot-skipping-premarket-review-vz2up8avf og:image: https://api.daily.dev/og/posts/vZ2up8avf.png og:image:alt: FDA picks Dexcom for TEMPO pilot, skipping premarket review og:image:width: 1200 og:image:height: 630 og:locale: en --- > ## Documentation Index > Fetch the complete documentation index at: https://daily.dev/llms.txt > Use this file to discover all available pages before exploring further. # FDA picks Dexcom for TEMPO pilot, skipping premarket review **[The Next Web](https://daily.dev/sources/tnw)** · 5 min read · 0 upvotes · 0 comments ## Summary The FDA has selected Dexcom as the first participant in its TEMPO pilot program, which allows digital health devices to reach Medicare patients before receiving formal premarket authorization. Under the enforcement discretion mechanism, Dexcom's Glucose Health Program can operate within the CMS ACCESS payment model — a ten-year initiative linking payments to measurable patient health outcomes — in exchange for collecting and sharing real-world performance data. The arrangement has been described as a regulatory side door, with legal analysts flagging unresolved oversight questions. TEMPO reflects a broader FDA shift toward loosening oversight of AI-enabled and wearable health technologies, as commercial players like Amazon, Microsoft, and OpenAI accelerate AI-mediated health offerings amid rising chronic disease rates. ## Full article daily.dev links to this article rather than hosting it. 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