Explaining Neuralink’s Human Trials Process
Ғылым және технология
Ellen: / ellenmaue
00:00 Intro
01:02 Neuralink FDA application an IDE (Investigational Device Exemption?)
07:13 Full FDA trial timeline?
09:02 Does approval for one indication = approval for all?
10:20 Who selects trial participants?
11:48 Who is the principal investigator?
13:42 FDA equivalent in other countries?
16:00 General trial license possible?
17:46 Expedite timeline by paying more?
21:28 Neuralink trials special?
22:57 Trial process for drugs vs devices?
24:53 IDE, PMA, De Novo?
27:55 Class 1, 2, & 3 devices?
30:44 How often do research groups and companies work together?
34:09 Would merging with Synchron expedite the trials?
41:28 Comparing drug vs device patent life after approval
43:59 Neuralink's breakthrough device designation won't make approval faster
45:05 Additional context for Ellen's job
46:26 Thanks for watching. Please like/ subscribe.
Neura Pod is a series covering topics related to Neuralink, Inc. Topics such as brain-machine interfaces, brain injuries, and artificial intelligence will be explored. Host Ryan Tanaka synthesizes information, shares opinions, and conducts interviews to easily learn about Neuralink and its future.
Support: / neurapod
Please consider supporting by joining the channel above, or sharing my other company website with retirees: www.reterns.com/. Opinions are my own. Neura Pod receives no compensation from Neuralink and has no affiliation to the company.
Edited by: Ryan Tanaka
#Neuralink #ElonMusk #HumanTrials
Пікірлер: 139
My favorite part about this channel is the time lapse between video's. I think it shows good discipline. You wait until you're sure you have solid content with new data and i love it ❤️
@NeuraPod
Жыл бұрын
Appreciate the thoughtful comment Shaolin. Thank you.
I am a 72-year-old woman, who has experience three traumatic brain injuries. One in 1993, another in 2010 and a stroke taking me all the way down, in 2017 where I am told that the back of my skull have been bashed in during the first two, truly accidental falls. Dean McGee eye institute, here in Oklahoma City, determined that 18% of my brain was dead. I was left 100% hemiplegic and probably Lost about 18% percent of everything. My eyesight, my speech, my ability to understand. Am I a candidate anywhere in this study? Through lex Friedman, I found Dr Andrew huberman and hang on his every word. Now, I am able to walk 24 steps, with a cane, just this week. There's something inside of me that just won't give up because I would if I could but I simply can't.
@godlikemachine645
Жыл бұрын
Try contacting neuralink through their website.
@ShirleyMcalpine
Жыл бұрын
@@godlikemachine645 much gratitude!
@NeuraPod
Жыл бұрын
Neura Pod and I are not formally affiliated with Neuralink. I suggest you reach out to Neuralink directly via the email on their website: www.neuralink.com/
I'm really enjoying these interviews, thanks for this content
@NeuraPod
Жыл бұрын
Thanks for the kind words Sathaniel.
It would be a dream to get picked for human trials I had a spinal stroke 6 years ago that left me paralyzed from waist down but now I got all my feelings and functions back I can move my toes on my right foot I just need that extra boost of electrical signal to be able walk again it's so frustrating at times that I can't do the simple things I used to do I pray the FDA approves this soon I just want to take a simple walk in the park
@CaliforniaMist
Жыл бұрын
Joining you in prayer 🙏 This should be fixed for you soon technology is getting so good
@MrJsbruins
Жыл бұрын
I was in a auto accident and I became paralyzed T/6-T-7 complete this would totally give me a opportunity to walk and feel the earth and do many other things that I require help with and totally give me total independence to live my life out to the fullest.
What a great resource to know! My previous familiarity with this subject matter is from occasional deep dives by Skeptics Guide to the Universe, but it's great to hear from a true expert in the area. Thanks for this!
@NeuraPod
Жыл бұрын
Thanks for watching Doug.
I watch this at almost double speed and it's perfect. I'm 58, have recently discovered I'm autistic ADHD,. I'm also diagnosed with anxiety depression and epilepsy and tinnitus. Thank you for all hard work and videos.
Neuralink's show and tell event is delayed, no longer on Halloween, it's rescheduled for November 30th!!
@otakugamer4340
Жыл бұрын
thx for the information
@ShirleyMcalpine
Жыл бұрын
Is that a delay? Doesn't seem like it to me.
@GdUpG2Gmafia
Жыл бұрын
@@ShirleyMcalpine a full month delay, plus it takes away the thought of the event being Halloween related!!
@alanbrady420
Жыл бұрын
Nice one 👍🏻
@ShirleyMcalpine
Жыл бұрын
@@GdUpG2Gmafia yes! I stand corrected. I'm an old saying a woman kind of slow on dates. Sorry about that.!
THANK YOU!
@NeuraPod
Жыл бұрын
Thanks for watching Zin.
We can only wait, but you can't say that you didn't get enough information from this site...keep up the good work!
@NeuraPod
Жыл бұрын
Appreciate the kind words. Thanks cdl340100
Thank you!
@NeuraPod
Жыл бұрын
Thanks for watching Paul.
How about language understanding with nuralink? Do you have to train the database? How long does it take?
Thank you.
@NeuraPod
Жыл бұрын
Thank you for watching fiddler John.
Yes! New video!
@NeuraPod
Жыл бұрын
Thanks for your continued support Magnamic.
Exciting times!!!
I'm a c-6 quad and ready to sign up!
Thx for the updates. I would sign up for human trials but I'm in Canada. 👾♥️
Your doing a great job girl, I got my ears on👂👋✌️in👋🤓.
I do understand the importance of a proper procedure when it comes to the approval a drug or a device to be safely used for humans. However this whole thing sounds like it introduces lots of opportunities for bureaucracy and delays (and who knows, maybe political interests and what not...)... I'm not saying that these are necessarily present and am not acusing anyone of anything, yet the more chances for bureaucracy there are, the higher the probability that it occurs...
How does one with Epilepsy qualify and or enter the process?
great guests!
@NeuraPod
Жыл бұрын
Thanks Julian.
I wonder if the Link and other invasive BCI are magnetic. If someone ran a big magnet over the patient's head, can they affect the threads and move them around? Seems like a big risk to me.
@godlikemachine645
Жыл бұрын
I'm sure they wouldn't be foolish enough to use magnetic threads.
@jonbong98
Жыл бұрын
Unnecessary worry, relax
Where to sign up for NEURALINL IMPLANT?
When neuralink will be available for peraolegic
Interesting.
Where do I (30yr quad) sign up?
Sooner the better, we are lagging behind, need this to add pace to developments.
hey im in canada any info whom i can contact about human trials i mite know of someone whom mite qualify for it and im curious so i figured id ask id yas know whom to contact
@NeuraPod
Жыл бұрын
Neura Pod and I are not formally affiliated with Neuralink, so I suggest you email the address listed on their company website.
thank you
@NeuraPod
Жыл бұрын
Thanks for watching.
I hope to have one of these installed one day
@ronhammersmith2324
Жыл бұрын
What would you like to do with it?
@alanbrady420
Жыл бұрын
Something to fix the pain I get having two prolapsed discs and having one operation already after five years or so the pain came back and another operation is too risky, it’d be nice to have internet access within my mind also 😏
@ronhammersmith2324
Жыл бұрын
@@alanbrady420 I totally get the pain treatment!
@MrJsbruins
Жыл бұрын
@@ronhammersmith2324 I would just like to gain my independence back and go for walks and definitely get to walk my daughter down the isle someday.
@MrJsbruins
Жыл бұрын
I will volunteer to be the Test patient…
FINISH human trials? I did not even know they BEGAN human trials
@NeuraPod
Жыл бұрын
In the process of beginning.
@bicyclexx7
Жыл бұрын
On the fence
wow.. this really makes me feel like the FDA is in the way of progress in a major way.. There must be some way to speed up this process- I mean there should be. Improving health is going to have to become an outside the US thing at these slow speeds. Technology moves so much faster than our government.
@tomh1727
Жыл бұрын
yeah sadly the same problem when it comes to space travel
@emmelineashcroft6482
Жыл бұрын
After covid we know we can develop new medicines in a years time. We've just decided not too now for some reason. But AI may allow us to simulate humans for medicine better than trials can be conducted. So in thecoming decades we may move away from doing trials. But regulation will likely slow us down.
@JZGreengo
Жыл бұрын
@@tomh1727 lmao there’s no FDA approval for space travel, value of cures is far greater than space travel at this time because imagine this, we go to mars, bunch of people get sick and die, if we get more medically advanced and control our health better we can definitely do some crazy space traveling
@tomh1727
Жыл бұрын
@@JZGreengo oh yeah was the FAA haha
But this technology can develop rapidly in the future and be better than it is now, until new inventions of the human mind appear in the future or in the present, and I expect that human brain technologies and brain-computer interfaces will have a great future.
Hey , why did Elon postpone nueralink day ?
what's up with the comments here? it's like 80% people who hate neuralink.
@chainfn7311
Жыл бұрын
Weirdos
@aeeevTHEBESTYOUTUBERXDDD
Жыл бұрын
Bots
@science_and_technology6
Жыл бұрын
But this technology can develop rapidly in the future and be better than it is now, until new inventions of the human mind appear in the future or in the present, and I expect that human brain technologies and brain-computer interfaces will have a great future.
🔥
@NeuraPod
Жыл бұрын
Thanks Rocky.
I'll volunteer 🤯🤖 had DBS in March
Respect Mr Elon Musk!
@NeuraPod
Жыл бұрын
:)
@molcay8355
Жыл бұрын
Ellen maue ? Hehehe
🖐️
How do I try the synchron chip in my mind because I want knowledge and superpowers
@NeuraPod
Жыл бұрын
I don't have any connections to Synchron
Resisting mi urge to troll... hopefully someone understands why. Overall, great video 👍
do these ones have the time travel in them or are those special nanorobots being used by someone else at your lab?
@iamzid
Жыл бұрын
bro, you might need to put the pipe down.
@trinitysingularityzombiech7836
Жыл бұрын
@@iamzid maybe i turn elon in for 9/11 cover up reason why he left his kids
@godlikemachine645
Жыл бұрын
Cocaine is a helluva drug, huh?
@iamzid
Жыл бұрын
@@trinitysingularityzombiech7836 well if you know something about it wouldn't it be your duty to turn him in? you'd be a bad person if you kept that sort of knowledge to yourself.
Black mirror when possible??
@gridcoregilry666
Жыл бұрын
soon, 10-20 years? maybe 30?
👍Ryan, I would be the first volunteer. I would build a Neuralink clinic in 🌏Lismore Base Hospital. 🌏 When is the big question??????
Amazing opportunity for humanity. I believe the FDA could become a political uphill Battle. Tweets
Are you lot actually working for neurolink, or just fans, just to ask
@NeuraPod
Жыл бұрын
Just fans.
Wow. 30 to 90 days to get FDA feedback. No wonder the American economy grows at such a slow 2% pace, literally all of our permitting processes are artificially constricting and slowing down our economic growth. It should not take 90 days to get a permit or an answer from a permitting agency. It should only take one or two weeks. This must change, and the only party talking about deregulation of any sector is the Republican Party, not the Democrats.
If I was on a wheelchair I’ll right away do the neural link
So it’s going to take 7 years before we can plant these in our brains?
@NeuraPod
Жыл бұрын
Potentially a little sooner. Depends on what condition you have or do not have though.
23:02, I'm extremely interested in this subject. That said, I would be a liar if I pretended to understand this conversation. A more simplistic break down of the conversation would be greatly appreciated. Yeah, go ahead and make fun of me for being Old, but don't ever make fun of me for trying to understand things...
@NeuraPod
Жыл бұрын
At the particular timestamp you referenced, we were talking about FDA trials for drugs (pills) vs trials for devices
Seems like it may be faster for Neuralink to develop an advanced BCI using just monkeys and boosting their inteligence on the way :)
@NeuraPod
Жыл бұрын
Yeah, haha- actually though. I wonder if this would be possible from a regulatory standpoint
@vlastekk
Жыл бұрын
@@NeuraPod Nah. As the monkeys would get smarter, they would probably start their own FDA :D
Silence is not acceptance! Unless, of course, you are the US government.
So... Am I the only one or does anyone else sense some serious vibes between these two?
@yahanaashaqua
Жыл бұрын
Could be. Who knows ! 🤷♂️ The content is legitly good, that's all that really matters
I would like to become a test subject not because of brain injury or mrducsj reasons but I believe wholeheartedly that we are all telepaths and telepathy is part of the key points of the ancient knowledge that has been suppressed Thru societal conditioning. With telepathy comes a universal understanding which connects. Empathy and compassion for all not greed violence and separation
Pooters…
Great Video! is it just me who got extremely focused how when she says "hm", in the end it looks like a moan of someone waking up. Damn..... i really need ADHD remedies.
IF THERE IS NO RESPONSE, GO AHEAD. - US GOVT
Too slow, need to expedite NOW!!
Okay but why do they all look like they would torture a monkey just for fun?
@alwaysyouramanda
Жыл бұрын
“No response means yes” typical of someone with no light being their eyes. They learned that one in college.
Ai in your head = millionaire🤔….
Are we going to have USB ports in our skulls?😨
@jonbong98
Жыл бұрын
No
@NeuraPod
Жыл бұрын
No. Will be wireless via Bluetooth.
Will the fatality rate be lower for humans than it was for pigs, sheep, and chimps? Will this comment survive the narcissism of Muskrats?
this tec will end humanity.
@zinzhao8231
Жыл бұрын
Not doing it will end humanity
@ShirleyMcalpine
Жыл бұрын
Or expand! Let's wait and see.
@johnbenson3024
Жыл бұрын
It has the potential to end humanity in the same way farming ended humanity. Humans were never the same
@godlikemachine645
Жыл бұрын
Tell that to paraplegics.
@ShirleyMcalpine
Жыл бұрын
@@johnbenson3024 LOL! That's a backwards comment to indicate that you're all for what neuralink and Elon is doing today!