FDA selects 1st digital health device pilot participant

Dexcom has been chosen by the FDA as the inaugural participant in its TEMPO pilot program, marking a significant step toward regulating digital health devices. This initiative aims to evaluate how such technologies can improve patient outcomes, particularly in chronic care management. With the FDA's backing, Dexcom plans to integrate its glucose monitoring program within CMS's ACCESS Model, potentially setting a new standard for how digital health tools are assessed and implemented in healthcare. This move underscores the growing importance of digital health in modern medicine and the FDA's role in ensuring their safety and efficacy.