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

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage ...

The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway ...

The FDA has released draft guidance outlining an approval pathway for individualized therapies aimed at ultra-rare diseases, building on a framework first outlined by agency leaders in November. The ...

Clinician-focused platform reaches 96% accuracy on the United States Medical Licensing Examination (USMLE), outperforming industry peers on standardized tests MONTREAL--(BUSINESS WIRE)--Pathway today ...