The FDA and CMS announced a new regulatory pathway—Regulatory Alignment for Predictable and Immediate Device, or RAPID—to speed Medicare national coverage decisions for breakthrough medical devices. The program aims to reduce delays between FDA authorization and CMS coverage determinations by aligning the two agencies earlier. Under RAPID, eligible devices receive a proposed national coverage determination on the same day they get FDA authorization, followed by a mandatory 30-day public comment period. CMS said coverage and payment could arrive as early as two months after authorization, versus about a year or more under prior processes. Industry impact: the move targets time-to-reimbursement constraints that can slow device adoption, potentially improving commercialization timelines for high-impact diagnostics and therapeutic devices after breakthrough designation.