The U.S. FDA has announced that Dexcom is the first participant in its TEMPO Digital Health Pilot Program, which allows certain digital health devices to be exempt from premarket review while collecting real-world data through Medicare. Dexcom plans to use AI and continuous glucose monitoring technology to screen for prediabetes and type 2 diabetes, marking a deep integration of regulatory innovation and payment reform.
The U.S. FDA has selected Dexcom as the first participant in the TEMPO digital health device pilot. The AI-driven blood glucose management program will be granted exemption from certain premarket approval requirements, while collecting real-world data through Medicare.
MiniMed launches the Abbott-manufactured Instinct continuous glucose monitor in Europe, targeting over 4.5 million Abbott CGM users, aiming to drive insulin pump sales growth through sensor selection.
At the American Diabetes Association Scientific Sessions, Insulet, MiniMed, Dexcom, and Abbott showcased cutting-edge technologies including fully closed-loop insulin delivery systems, new evidence for continuous glucose monitoring, and multi-analyte sensors.
As GLP-1 drugs evolve from injectables to oral, multi-target, and RNA therapies, the entire metabolic disease treatment market is undergoing profound changes. This article analyzes the latest industry trends, key company strategies, and development directions over the next 3-5 years.