Philip Nelson

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Latest Posts › Food and Drug Administration (FDA)

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Recent Machine Learning Studies in Medical Imaging Applying FDA Principles

Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete with them. A review of AI methodologies...more

8/20/2025 / Algorithms , Artificial Intelligence , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Popular , Regulatory Requirements

FDA Statements and Patent Disclosures

Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often seek U.S. patent protection so...more

8/11/2023 / Food and Drug Administration (FDA) , Medical Devices , Patent Infringement , Patent Litigation , Patents , Pharmaceutical Patents , USPTO

FDA Updates Cybersecurity Guidance

(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more

6/2/2023 / Cybersecurity , Data Privacy , Data Protection , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Medical Devices , Popular

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