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 ...

As technology advances and medical devices become an increasingly integral part of healthcare, understanding the regulatory pathways for medical devices is critical for many biotechnology companies ...

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 ...

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 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 ...

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 ...

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 ...

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 ...

Eskandanian is a senior research scientist at MedStar Health Research Institute, program director of the BARDA-funded SPARK for Innovations in Pediatrics, and founding principal investigator of the ...

The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to gain reimbursement.