The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting. The ...

The FDA and CMS have unveiled the RAPID coverage pathway to align regulatory and coverage processes for breakthrough medical devices, aiming to cut delays for Medicare patients. The initiative enables ...

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 ...

Basics and Beyond - Keeping Up with FDA Medical Device Submission Programs and Pilots” session MEDevice Boston 2026 on August ...

On June 25, 2026, UpDoc Inc., a clinical AI company, announced that it received clearance from FDA for what the company describes as the ...

The Centers for Medicare & Medicaid Services’ (CMS) FY 2027 Inpatient Prospective Payment System (IPPS) Proposed Rule is framed as a hospital payment update, but for many FDA-regulated companies, its ...

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 US FDA and CMS have introduced the RAPID coverage pathway to shorten the time between FDA approval and Medicare coverage for certain breakthrough medical devices. The initiative aligns regulatory ...

CMS and the FDA have launched a new coverage pathway to expedite Medicare access to certain medical devices. The Regulatory Alignment for Predictable and Immediate Device coverage pathway is designed ...