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 ...

A key component of the EMA's innovative device pathway is to offer expert support to manufacturers of breakthrough medical ...

In a new proposal to harmonize regulatory pathways for personalized medical devices, the International Medical Device Regulators Forum (IMDRF) is looking to crack down on the “questionable use of ...

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 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 ...

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 ...

Italy has introduced national guidelines for early feasibility studies (EFS) in medical devices, creating a fast-track approval process with no fees and streamlined documentation. The framework, fully ...

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 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 ...