FDA Emphasizes Use of Real-World Evidence for Medical Device Makers
The U.S. Food and Drug Administration (FDA) has increasingly emphasized the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. As medical technologies evolve and data sources...
FDA Announces “RAPID” Pathway for Expedited Access to Breakthrough Devices by Medicare Population
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed to expedite access to certain FDA-designated Class II...
Is Your IP Ready? Navigating IP Challenges for Commercial-Stage Technologies in Due Diligence and M&A
Presenting as part of an LSI ’26 panel, Knobbe Martens partners Kregg Koch and Sabing Lee joined fellow panelists to explore the complexities of intellectual property management for commercial-stage technologies in the medtech industry, and the...