The U.S. Centers for Medicare & Medicaid Services moved forward with a new proposed device coverage pathway, laying out the Regulatory Alignment for Predictable and Immediate Device (RAPID) track as an alternative to TCET. CMS issued a proposed notice outlining how breakthrough medical devices may be reviewed and covered more quickly. RAPID aims to replace the Transitional Coverage for Emerging Technologies pathway with a mechanism that emphasizes predictability and earlier coverage determinations. For med-tech and device-adjacent biotech, the procedural change can materially affect launch timing and evidence planning. Stakeholders will likely focus on how CMS aligns evidence requirements with existing regulatory steps, and how the pathway affects coverage evidence generation after approval. The proposal also signals CMS’ intent to streamline payer review cycles for innovative technologies while maintaining governance over clinical benefit documentation.