📊 Industry Moves
Dexcom is the FDA’s first TEMPO pilot participant, gaining an exemption from premarket authorization to collect real-world glucose data through Medicare for an AI prediabetes screening tool. For CGM users, it means regulators now see continuous glucose monitoring as early-disease screening, not just glucose management.
Marty’s Take:
This pilot matters less for Dexcom than for the precedent it sets: FDA just agreed to treat a glucose sensor like software, not a pacemaker. Expect Apple, Garmin, and Whoop to push hard for the same real-world-data pathway on blood pressure and glucose features already sitting in their labs. The gatekeeper shrank, and the best fitness trackers of 2027 will look a lot more medical.
Source: MedTech Dive
