Ariel Seeley

Ariel Seeley

Morgan Lewis

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Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more

6/11/2025  /  Algorithms , Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Regulatory Oversight , Regulatory Requirements

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

6/4/2025  /  Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements
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