GottaLaff,
@GottaLaff@mastodon.social avatar

Exclusive: A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon '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/

lawyersgunsnmoney,
@lawyersgunsnmoney@mstdn.social avatar

@GottaLaff That is a very good question - the Human Subject Research regulations prohibit that

ChrisHolladay,
@ChrisHolladay@mastodon.social avatar

@GottaLaff
I thought we were years away from this bullshit....
If billionaires can throw their money away on rockets ,satellites,and brain devices,they can pay their fucking taxes

Money talks
Bullshit walks

mloxton,
@mloxton@med-mastodon.com avatar

@GottaLaff
Lots of questions

GottaLaff,
@GottaLaff@mastodon.social avatar

@mloxton We need lots of answers.

mloxton,
@mloxton@med-mastodon.com avatar

@GottaLaff
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?

GottaLaff,
@GottaLaff@mastodon.social avatar

@mloxton Hope you get your answers to those too

Chancerubbage,
@Chancerubbage@mastodon.social avatar

@GottaLaff @WarnerCrocker

I’m thinking they skirted around whatever regulations allow auditory skull implantations with the deaf, and a whole lot of paperwork for those volunteering for the procedure.

nosmaharba,
@nosmaharba@mastodon.world avatar

@GottaLaff
I think the FDA is ill equipped to be the Tech Admin.

Their answer should have been "umm no. You're thousands of living monkeys away from human testing"

Blinxeto,
@Blinxeto@mastodon.social avatar

@GottaLaff

Exactly!!!

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