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 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 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 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 Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...

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 ...

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 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 ...