CMS FDA launch pathway expedites Medicare coverage for breakthrough medical devices, enabling payment within two months of FDA authorization.

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

The agencies’ initiative is intended to speed up the processes involved in medical devices’ securing Medicare coverage once ...

The RAPID pathway could cut the wait for Medicare coverage from over a year to about 2 months after FDA market authorization ...

Eligible devices could be covered by Medicare as soon as 2 months after market authorizati ...

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...

Kezar Life Sciences is a biotech, not a medical device company, but the mechanics work the same way for any company with a ...