FDA Names Its First Company in a Pilot That Lets Some Digital Health Devices Skip Premarket Review

The company will run a glucose health program that combines data from its sensors with information on nutrition, physical activity, sleep, and stress. The First Company Through the DoorDexcom was selected for its Glucose Health Program, which the FDA says it will continue to evaluate for its intended use during the pilot. The FDA's Technology-Enabled Meaningful Patient Outcomes pilot for digital health devices, developed with the CMS Innovation Center. Dexcom, for its Glucose Health Program, which aims to identify and manage prediabetes and type 2 diabetes. Does this mean devices skip FDA review entirely?