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+--- Thread: Article Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) (/thread-13914.html)
Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - C C - Apr 3, 2023
Facing animal-abuse investigations, Elon Musk’s neurotech company is stumbling
https://spectrum.ieee.org/neuralink-seeks-fda-approval
EXCERPTS: Neuralink, the neurotechnology company founded by Elon Musk, is at best having a rough initial go-round with the Food and Drug Administration’s human-trials application process. The company also faces additional investigations by two other U.S. government agencies. These setbacks and the broad, cure-all expectations that its founder has placed on the company’s neural implant could now incite increased scrutiny from regulators. By contrast, however, other neurotech companies have, to date, managed largely to avoid such intense regulatory scrutiny.
[...] Ongoing investigations will not likely factor directly into how the FDA evaluates the data in Neuralink’s next IDE application, but it will likely complicate the process. Data from diseased animals and contaminated equipment may need to be rejected, says Victor Krauthamer, visiting professor of biomedical engineering at George Washington University and the former acting director of the FDA’s Division of Neurological and Physical Medicine Devices. “If the experiments are tainted in some way, then the FDA may require new data. If the animal studies are questionable, they will have to be redone,” he says.
Further complicating Neuralink’s application are the many claims Musk and other company representatives have made regarding The Link’s purportedly extensive list of capabilities... (MORE - missing details)
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - May 26, 2023
(Apr 3, 2023 07:30 PM)C C Wrote: Facing animal-abuse investigations, Elon Musk’s neurotech company is stumbling
https://spectrum.ieee.org/neuralink-seeks-fda-approval
EXCERPTS: Neuralink, the neurotechnology company founded by Elon Musk, is at best having a rough initial go-round with the Food and Drug Administration’s human-trials application process.
Neuralink announced today that they just received FDA approval for their first human trials. Details on the nature of those trials will be forthcoming.
https://twitter.com/neuralink/status/1661857379460468736
My guess is that they might just be implanting recording electrodes into functioning human brains to map things out, so to speak.
At most, it might be a repeat of what they have already accomplished with monkeys, namely enabling humans to work a computer keyboard and mouse just by thinking about performing those actions. If that works (and it worked quite well with the monkeys who could operate video games even faster than humans can with hand controllers) it might prove to be very valuable to quadriplegics.
I think that the goal of returning useful movement and feeling to those quadriplegics is still a long ways off.
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - Sep 19, 2023
Neuralink are presently recruiting test subjects for their first human trials. These first test are largely to evaluate the safety both of their implants and their surgical robot in human beings. It's also intended to get early data on the functionality of the implant in allowing paralyzed individuals to control devices by thinking about doing so.
They say:
"We’re excited to announce that recruitment is open for our first-in-human clinical trial!
If you have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS), you may qualify. Learn more about our trial by visiting our recent blog post."
https://neuralink.com/blog/first-clinical-trial-open-for-recruitment/
https://twitter.com/neuralink/status/1704189132530974954
https://neuralink.com/pdfs/PRIME-Study-Brochure.pdf
![[Image: F6Z9OXQWAAAav1P?format=jpg&name=4096x4096]](https://pbs.twimg.com/media/F6Z9OXQWAAAav1P?format=jpg&name=4096x4096)
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - Nov 22, 2023
https://twitter.com/neuralink/status/1727135227565547810
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - Jan 30, 2024
"The first human received an implant from @Neuralink yesterday and is recovering well.
Initial results show promising neuron spike detection."
https://twitter.com/elonmusk/status/1752098683024220632
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - C C - Feb 5, 2024
Elon Musk’s Neuralink brain chip: what scientists think of first human trial
https://www.nature.com/articles/d41586-024-00304-4
EXCERPT: Neurotechnology researchers are cautiously excited about Neuralink’s human trial. “What I hope to see is that they can demonstrate that it is safe. And that it is effective at measuring brain signals — short term, but, most importantly, long term,” says Mariska Vansteensel, a neuroscientist at University Medical Centre Utrecht in the Netherlands and president of the international BCI Society.
But there is frustration about a lack of detailed information. There has been no confirmation that the trial has begun, beyond Musk's tweet. The main source of public information on the trial is a study brochure inviting people to participate in it. But that lacks details such as where implantations are being done and the exact outcomes that the trial will assess, says Tim Denison, a neuroengineer at the University of Oxford, UK.
The trial is not registered at ClinicalTrials.gov, an online repository curated by the US National Institutes of Health. Many universities require that researchers register a trial and its protocol in a public repository of this type before study participants are enrolled. Additionally, many medical journals make such registration a condition of publication of results, in line with ethical principles designed to protect people who volunteer for clinical trials. Neuralink, which is headquartered in Fremont, California, did not respond to Nature’s request for comment on why it has not registered the trial with the site.
Nature examines how Neuralink’s implants compare to other BCI technologies, how the trial will advance BCIs and researchers’ concerns... (MORE - missing details)
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - Mar 20, 2024
Interview with Neuralink’s first human subject, a young guy who broke his neck in a freak diving accident and is now a quadriplegic. (He can move his neck and shrug his shoulders, but not his arms or below that.) Apparently he was a video game player prior to his accident. Once he figured out how to control a computer by using "the Force", by just willing a curser to move (as opposed to contemplating moving) he says he stayed up to 6 am successfully relearning to play his computer games. He says he is reading (ebooks I assume) and trying to learn foreign languages (Japanese and French).
So apparently it's just as easy for humans to get the hang of it as it was for the Neuralink monkeys.
Perhaps now they should create a mind controlled motorized wheelchair that can be commanded just by intending it to move. Maybe eventually give it some Optimus arms.
https://twitter.com/neuralink/status/1770563939413496146
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - Mar 21, 2024
Neuralink’s latest project is called "Blindsight". It involves implanting electrodes into a blind person's visual cortex enabling them to experience pixels of perceived light.
Elon says:
"I should mention that the Blindsight implant is already working in monkeys.
Resolution will be low at first, like early Nintendo graphics, but ultimately may exceed normal human vision.
(Also, no monkey has died or been seriously injured by a Neuralink device!)"
https://twitter.com/elonmusk/status/1770817187285995939
RE: Neuralink’s FDA troubles are just the beginning ("Left sics the dogs on Elon" style) - Yazata - Mar 23, 2024
Noland Arbaugh writes, "Twitter banned me because they thought I was a bot,
@X and @elonmusk reinstated me because I am.
https://twitter.com/ModdedQuad/status/1771230292839145541
Elon writes: "First ever post made just by thinking, using the @Neuralink Telepathy device!"
https://twitter.com/elonmusk/status/1771287982693060783
More from Noland
https://twitter.com/ModdedQuad/status/1771298116719002100
Noland has already made hundreds of pages of notes about how to improve the device.