The FDA has named the first company in a pilot program that takes a different approach to regulating digital health devices, letting certain products reach patients while evidence about them is gathered in real use rather than beforehand.
The agency announced on July 22 that Dexcom, a maker of continuous glucose monitors, is the first participant in the Technology-Enabled Meaningful Patient Outcomes pilot, known as TEMPO. The company will run a glucose health program that combines data from its sensors with information on nutrition, physical activity, sleep, and stress.
