Last week, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) unveiled a proposed program aimed at dramatically accelerating Medicare coverage for ...

The US Centers for Medicare & Medicaid Services (CMS) and the US Food and Drug Administration (FDA) have introduced a new coverage pathway designed to expedite access to certain FDA-designated Class ...

The RAPID coverage pathway is designed to address the historically significant lag (sometimes referred to as the “valley of death”) between the point at which a medical device receives FDA market ...

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage at the same time under a new coverage pathway announced Thursday by the FDA ...

Dublin, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The "Understanding Medical Device Regulatory Pathways - 510(k), PMA & Exemptions (January 15, 2026)" training has been added to ResearchAndMarkets.com's ...

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough ...

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Practical Guide to FDA Medical Device Submissions - 510(k), PMA and Exemption Pathways (Apr 14, 2026)" training has been added to ...

The RAPID pathway is designed to accelerate access to certain FDA-designated Class II and Class III devices for people with Medicare coverage, CMS and FDA officials said. (Inna Knot/GettyImages) The ...