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Wire · opportunities

Breaking news for breakthrough devices: CMS proposes RAPID Pathway

12 August 2026 · By · Wire by Fusion42

Published

12 August 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at hlc.com →

◆ Verified

Fusion42 · 12 August 2026 · Fusion42 review

CMS proposes the RAPID pathway to close the gap between FDA market authorization and Medicare coverage for breakthrough medical devices by requiring clinical evidence of improved health outcomes for Medicare beneficiaries during IDE studies.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 7 Aug 2026 and 12 Aug 2026.

◆ ◆ The Wire takeaway

You now have a clearer route to Medicare coverage if your device holds FDA breakthrough status and meets RAPID requirements, shortening commercialisation timelines and boosting market access.

◆ Coverage

2 sources · first reported 7 Aug 2026 · latest 12 Aug 2026

◆ Related on Wire

◆ Topics

Medtechmedicare-coveragebreakthrough-devicesFDArapidity-pathwayIDE-studiesmedical-devices