2025 MedTech Fast Track: FDA Breakthroughs & CMS Coverage Acceleration

Medical Device Global Market Access · Jun 5, 2025 · 5m

This episode unpacks the 2025 landscape for the FDA's Breakthrough Devices Program and the transformative new CMS Transitional Coverage for Emerging Technologies (TCET) pathway. We explore how these initiatives are accelerating device clearance and Medicare coverage, including the impact of over 1,000 Breakthrough designations granted by September 2024 and TCET's August 2024 finalization. We delve into the benefits, eligibility, and current limitations, such as TCET's five-device annual cap and exclusion of diagnostics. Key Questions: • How is the FDA's Breakthrough Devices Program evolving…