The Legal Intelligencer: AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe

April 14, 2025

In an article published by The Legal Intelligencer, Pittsburgh-based Associate Cody Madison and Patent Agent Lisa Geary  examine the 2024 guidelines from the U.S. Patent and Trademark Office (USPTO) on patent eligibility for SaMD, the regulatory requirements established by the U.S. Food and Drug Administration (FDA), and a comparison of how these devices are regulated and patented in both the United States and Europe.

Read the article here (subscription required). 

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