FDA Selects Dexcom for Pilot Program Allowing Early Access to Unapproved Devices for Medicare Patients

The US Food and Drug Administration (FDA) announced Dexcom as the first company chosen to participate in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program. This initiative permits certain digital health devices to be offered to Medicare beneficiaries prior to formal FDA authorization through a policy known as enforcement discretion. Rather than issuing a full approval, this program allows earlier access to promising medical technologies.