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Exclusive: A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon #Musk's Neuralink before allowing the brain implant company to test its (mastodon.social)
submitted 7 months ago by [email protected] to c/[email protected]
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Exclusive: A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon #Musk's Neuralink before allowing the brain implant company to test its device in humans. https://www.reuters.com/business/healthcare-pharmaceuticals/us-lawmaker-seeks-answers-fda-inspection-musks-neuralink-2024-03-26/

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[–] [email protected] 2 points 7 months ago

@[email protected]
I think I know the answer to the main question, and it is a bit boring.

I expect that Neuralink got approval for human testing because they used a "same as" application, and could cite many other very similar implants that had been previously approved for other applicants. (2002, 2006, etc)

I want to know how this patient selected, the end points, what is this "issue" that the patient mentioned, what outcomes and adverse effects are being monitored, what are the rollback options?