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 pediatric and orphan pipeline is already the smallest, slowest, and least capitalized segment of the device industry,” ...

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 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 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 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.

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 ...

Bipartisan senators introduced the Health Tech Investment Act (S. 1399), which would establish a Medicare reimbursement pathway for FDA-cleared medical devices that utilize artificial intelligence and ...