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From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

Alcon Vision LLC ARNOLD & PORTER Artificial Intelligence Brain Califf, Robert M Drugs (Pharmaceuticals) Ethics and Official Misconduct Food and Drug Administration Kennedy, Robert F Jr Medical Devices Medicine and Health Musk, Elon Neuralink Corp Presidential Election of 2024 Regulation and Deregulation of Industry Research Shuren, Allison W Shuren, Jeffrey E

From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.

By Christina Jewett

FDA Names a New Chief of Medical Devices

Appointments and Executive Changes Ethics and Official Misconduct Food and Drug Administration Medical Devices Politics and Government Regulation and Deregulation of Industry Shuren, Jeffrey E

FDA Names a New Chief of Medical Devices

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.

By Christina Jewett

Lawmakers Seek Inquiry Into F.D.A. Device Chief’s Potential Conflicts

Conflicts of Interest Ethics and Official Misconduct Inspectors General Medical Devices Regulation and Deregulation of Industry United States Politics and Government

Lawmakers Seek Inquiry Into F.D.A. Device Chief’s Potential Conflicts

A top medical device regulator’s work overlapped at times with his wife’s legal representation of clients with business before the agency.

By Christina Jewett

He Regulated Medical Devices. She Represented Their Makers.

Alcon Allergan Inc Allison Shuren Arnold and Porter Ethics and Official Misconduct Food and Drug Administration Medical Devices Regulation and Deregulation of Industry Shuren, Jeffrey E Theranos Inc

He Regulated Medical Devices. She Represented Their Makers.

Ethics rules barred Dr. Jeffrey E. Shuren from working on matters involving clients of his wife’s law firm. But he did not always step aside.

By Christina Jewett