CMS and FDA announce RAPID coverage pathway to accelerate patient access to life changing medical devices

FDA

23 April 2026 - New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.

Today, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.

Read FDA press release

Michael Wonder

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Michael Wonder

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US , Regulation , Market access , Device