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 CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices. The pathway, called the Regulatory Alignment for ...

The Centers for Medicare & Medicaid Services has introduced a new coverage pathway for Medicare beneficiaries to get expedited coverage for breakthrough medical devices. On Thursday, CMS and the Food ...

The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting. The ...

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 ...

The US Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have introduced the RAPID coverage pathway to shorten delays between market approval and Medicare coverage ...

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 ...

It appears that authors Anika Kumar and colleagues (November 2023) are potentially misinformed about the regulatory landscape in the US. According to the Food and Drug Administration (FDA), ...

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 ...