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

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

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

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

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 ...

The FDA and CMS have unveiled the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway to accelerate Medicare coverage for FDA-designated Breakthrough Devices. By aligning ...

“Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes. Dr. Shuren testified ...

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