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Perspective by Dr. Kip Ludwig: What does the recent Neuralink FDA IDE really mean?
No matter what, getting an Investigational Device Designation (IDE) for a brain implant from the Food and Drug Administration (FDA) isn’t trivial, so I’m happy for the Neuralink team. They have some really smart people whom I have a lot of respect for, even if as a whole their team doesn’t have much practical experience developing a regulated implantable medical device through to market.