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Today, the FDA identified a Class I Recall, the most serious type of recall: Medtronic expanded its 2018 recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic updated recommendations for people who may still be using the remote controllers, including instructions to stop using and return the remote controller. Find out more about this medical device recall: https://go.usa.gov/xMwr
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Today, the FDA launched Elsa, a generative AI tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people. Elsa in Action ➤ Accelerate clinical protocol reviews ➤ Shorten the time needed for scientific evaluations ➤ Identify high-priority inspections targets ➤ Perform faster label comparisons ➤ Summarize adverse events to support safety profile
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🎬 Watch our latest FDA Direct! We discuss: ✅ Major accomplishments including new AI tools for staff ✅ Efforts to modernize drug approval processes ✅ Initiatives to reduce harmful food additives ✅ Plans to combat illegal vaping products ✅ The future of FDA modernization Watch the full conversation: https://www.youtube.com/watch?v=lnx1Ikiawe4&list=PLey4Qe-UxcxbGI04rUjdaGyNhNnuP5cBO | U.S. Food and Drug Administration
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Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe! | U.S. Food and Drug Administration
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