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this post was submitted on 30 Jan 2024
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Has anyone a TL;DR why they could do that? Last time I heard anything about Neuralink they were mass killing animals with botched implants.
Enough animals died. Now humans have their turn
Fucking finally.
Username checks out
FDA had denied, company presumably made some sort of changes that were not publicized (or paid off the right people), FDA approved.
If you’ve ever dealt with getting a medical device approved by the FDA, you’d know they don’t fuck around. They’re so hardcore it’s scary.
there are ways around them. convince them your product is "substantially equivalent" and they don't look too hard, apparently. (see - hard silicone penile implants)
https://www.propublica.org/article/penis-enlargement-enhancement-procedures-implants
They famously didn't approve the wonder drug thalidomide.
Not when you're the wealthiest person in the world. All hurdles are trivial when you're wealthy.
In my experience, I've seen a muti billion dollar company denied new product testing for errors on paperwork.
My former employer had to etch "not for human use" in the devices because the FDA didn't clear them. They took them to use on sheep instead.
The FDA, as long as it doesn't fall prey to the revolving door like every other regulator, is extremely effective.
They were approved last year in May by the FDA for human trials
https://www.reuters.com/science/elon-musks-neuralink-gets-us-fda-approval-human-clinical-study-brain-implants-2023-05-25/
FDA fell asleep at the wheel
Recommend you watch Fall of the House of Usher on Netflix for three answer. Also because it's amazing.
no, you're amazing !
I heard there were some amazing people in this thread?
Looks like they were right