US Market Access: How CMS Reimbursement Fueled the CGM and Insulin Pump Boom

This episode explores the rapid adoption of Continuous Glucose Monitors (CGMs) and insulin pumps in the United States, detailing how changes in reimbursement policy, specifically from the Centers for Medicare & Medicaid Services (CMS) in April 2023, transformed these devices from niche products to mainstream standards of care for a growing number of people with both type 1 and type 2 diabetes. - How did CGM technology transition from a niche to a mainstream medical device in the U.S.? - What critical role did CMS play in expanding market access for CGMs? - Why are more people with type 2 diabetes now using CGMs than those with type 1? - What specific policy change in April 2023 opened the door for millions more patients? - How have both public and commercial insurance plans fueled the CGM boom? - What technological advancements are driving competition among manufacturers in 2025? - How are policy, technology, and data combining to reshape modern diabetes care? Navigating complex regulatory environments like the U.S. requires deep expertise. Pure Global offers end-to-end consulting for MedTech and IVD companies, leveraging local experts and advanced AI to streamline global market access. We develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative to ensure your product gets to market quickly and stays compliant. Whether you are a startup or a multinational, our solutions are tailored to your needs. Contact us at [email protected], visit our website at https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.