Explaining Neuralink’s Human Trials Process

Рет қаралды 26,429

Күн бұрын

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

@shaolinclips Жыл бұрын

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.

@ShirleyMcalpine Жыл бұрын

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/

@sathaniel_ Жыл бұрын

I'm really enjoying these interviews, thanks for this content

@NeuraPod Жыл бұрын

Thanks for the kind words Sathaniel.

@dougrogers629 Жыл бұрын

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.

@suppeeps5393 Жыл бұрын

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.

@keithwilcox7489 Жыл бұрын

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.

@GdUpG2Gmafia Жыл бұрын

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.!

@cdl340100 Жыл бұрын

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

@magnamic5614 Жыл бұрын

Yes! New video!

@NeuraPod Жыл бұрын

Thanks for your continued support Magnamic.

@zinzhao8231 Жыл бұрын

THANK YOU!

@NeuraPod Жыл бұрын

Thanks for watching Zin.

@sparkpaul Жыл бұрын

Thank you!

@NeuraPod Жыл бұрын

Thanks for watching Paul.

@fiddlerJohn Жыл бұрын

Thank you.

@NeuraPod Жыл бұрын

Thank you for watching fiddler John.

@ChrisDaubitz Жыл бұрын

I'm a c-6 quad and ready to sign up!

@svegritet Жыл бұрын

How about language understanding with nuralink? Do you have to train the database? How long does it take?

@ellieinspace Жыл бұрын

Exciting times!!!

@ConnoisseurOfExistence Жыл бұрын

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...

@SaposaBear Жыл бұрын

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

@gridcoregilry666 Жыл бұрын

great guests!

@NeuraPod Жыл бұрын

Thanks Julian.

@rocko100able Жыл бұрын

Your doing a great job girl, I got my ears on👂👋✌️in👋🤓.

@spectralvalkyrie Жыл бұрын

Thx for the updates. I would sign up for human trials but I'm in Canada. 👾♥️

@michaelmike5578 Жыл бұрын

How does one with Epilepsy qualify and or enter the process?

@RussInGA Жыл бұрын

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

@monikapatel5875 Жыл бұрын

Sooner the better, we are lagging behind, need this to add pace to developments.

@alanbrady420 Жыл бұрын

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…

@papadizastr Жыл бұрын

Interesting.

@HowDawgg Жыл бұрын

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.

@scifibri2376 Жыл бұрын

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

@chantalpique Жыл бұрын

Where to sign up for NEURALINL IMPLANT?

@Indianbeastpro Жыл бұрын

When neuralink will be available for peraolegic

@GWAForUTBE Жыл бұрын

Where do I (30yr quad) sign up?

@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.

@iamzid Жыл бұрын

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

@ramakrishna5480 Жыл бұрын

Hey , why did Elon postpone nueralink day ?

@Rocky_Anunnaki Жыл бұрын

🔥

@NeuraPod Жыл бұрын

Thanks Rocky.

@benjaminprewitt4583 Жыл бұрын

I'll volunteer 🤯🤖 had DBS in March

@valentinavanovac2109 Жыл бұрын

Respect Mr Elon Musk!

@NeuraPod Жыл бұрын

@molcay8355 Жыл бұрын

Ellen maue ? Hehehe

@yahanaashaqua Жыл бұрын

Resisting mi urge to troll... hopefully someone understands why. Overall, great video 👍

@sanbetski Жыл бұрын

thank you

@NeuraPod Жыл бұрын

Thanks for watching.

@science_and_technology6 Жыл бұрын

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

@garywaters6356 Жыл бұрын

Amazing opportunity for humanity. I believe the FDA could become a political uphill Battle. Tweets

@trinitysingularityzombiech7836 Жыл бұрын

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.

@rahulbanerjee6635 Жыл бұрын

Black mirror when possible??

@gridcoregilry666 Жыл бұрын

soon, 10-20 years? maybe 30?

@suchdevelopments Жыл бұрын

👍Ryan, I would be the first volunteer. I would build a Neuralink clinic in 🌏Lismore Base Hospital. 🌏 When is the big question??????

@luism5514 Жыл бұрын

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.

@paulmerritt9352 Жыл бұрын

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

@krishendrix773 Жыл бұрын

🖐️

@KHos73 Жыл бұрын

Are you lot actually working for neurolink, or just fans, just to ask

@NeuraPod Жыл бұрын

Just fans.

@SerPapus Жыл бұрын

If I was on a wheelchair I’ll right away do the neural link

@deanmousa3092 Жыл бұрын

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.

@dpchait7793 Жыл бұрын

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

@RobertLoPinto Жыл бұрын

Silence is not acceptance! Unless, of course, you are the US government.

@vlastekk Жыл бұрын

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

@westleywest7259 Жыл бұрын

Pooters…

@MichaelRichard_re Жыл бұрын

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

@cruzc5frc Жыл бұрын

IF THERE IS NO RESPONSE, GO AHEAD. - US GOVT

@monikapatel5875 Жыл бұрын

Too slow, need to expedite NOW!!

@otakugamer4340 Жыл бұрын

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.