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...
Jonathan Menkes Comments on Sports Trademark Trends and Generative AI in World Intellectual Property Review
In a recent interview with World Intellectual Property Review, Knobbe Martens Trademark and Brand Protection partner Jonathan Menkes, Co-Chair of the firm’s Sports and Gaming practice, shared insights on the...
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...
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