magnetosphere@fedia.io
on 27 Mar 2024 01:03
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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.
I think John Oliver has covered this one. In particular, how poorly the FDA handles food safety but discusses inadequate funding and bureaucratic inefficiencies as a whole.
elshandra@lemmy.world
on 27 Mar 2024 09:44
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You’re not wrong in any way, they definitely do need more funding. No matter how much you throw at it, the enormity of the task of making sure everything that wants to come to market is safe for humans… I can’t imagine how humans can even keep up.
Sure, the risks associated with brain implants are high, but it’s something you (hopefully) very consciously have to agree to. It’s more value to test some artificial sweetener to make sure it doesn’t give us diabetes.
ringwraithfish@startrek.website
on 27 Mar 2024 02:56
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Wouldn’t be surprised if they used the 510k loophole.
HessiaNerd@lemmy.world
on 27 Mar 2024 04:32
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No fucking way. It’s a PMA device. The rub is that M. it stands for market. As in clinical trials have a lower threshold.
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That is a very, very good question.
I think John Oliver has covered this one. In particular, how poorly the FDA handles food safety but discusses inadequate funding and bureaucratic inefficiencies as a whole.
You’re not wrong in any way, they definitely do need more funding. No matter how much you throw at it, the enormity of the task of making sure everything that wants to come to market is safe for humans… I can’t imagine how humans can even keep up.
Sure, the risks associated with brain implants are high, but it’s something you (hopefully) very consciously have to agree to. It’s more value to test some artificial sweetener to make sure it doesn’t give us diabetes.
Wouldn’t be surprised if they used the 510k loophole.
No fucking way. It’s a PMA device. The rub is that M. it stands for market. As in clinical trials have a lower threshold.