Tag: neuralink
Engadget Podcast: What’s up with Elon Musk’s Neuralink?
This week, we chat with Senior Editor Andrew Tarantola about Neuralink, Elon Musk’s brain computer interface (BCI) company. The FDA reportedly denied approval for human trials last week—Andy explains why that happened, as well as what BCIs could mean for humans in the future. Also, Cherlynn dives into the accessibility news from Microsoft’s Ability Summit.
Listen below or subscribe on your podcast app of choice. If you’ve got suggestions or topics you’d like covered on the show, be sure to email us or drop a note in the comments! And be sure to check out our other podcasts, the Morning After and Engadget News!
Subscribe!
Topics
-
What’s going on with Neuralink and BCI tech? – 2:05
-
Elon Musk goes after disabled Twitter employee, quickly apologizes – 19:52
-
Microsoft touts new accessibility tech at 2023 Ability Summit – 28:32
-
Sonos’ Era 300 speaker finally has spatial audio – 35:04
-
What we think of the Yellow iPhone and a few other colorful gadgets announced this week – 45:25
-
Working On – 51:49
-
Around Engadget: the reMarkable Folio is a very pretty e-paper keyboard – 54:28
-
Pop culture picks – 56:29
Livestream
Credits
Hosts: Cherlynn Low and Devindra Hardawar
Guest (Audio): Andrew Tarantola
Producer: Ben Ellman
Music: Dale North and Terrence O’Brien
Livestream producers: Julio Barrientos
Graphic artists: Luke Brooks
This article originally appeared on Engadget at https://www.engadget.com/engadget-podcast-elon-musk-neuralink-human-trials-denied-133016676.html?src=rss
Elon Musk said Neuralink is ready for humans. Regulators disagreed.
Application denied. That’s what regulators with the U.S. Food and Drug Administration (FDA) had to tell Elon Musk’s brain implant company, Neuralink, after it sought the green light to begin human trials.
Furthermore, it seems unlikely that Neuralink will receive an approval soon, at least not within any timeframes that Musk has previously mentioned.
The news of the FDA’s denial of Neuralink’s application comes from a new report by Reuters. The outlet spoke to more than half a dozen current and former employees who shared details of the rejection, which actually came about a year ago. The FDA’s denial was not publicly known before.
Musk has shared his grand vision for Neuralink a number of times over the years. According to Musk, once a Neuralink chip is implanted into a patient’s brain, it could help restore vision to the blind and even help paralyzed people walk again. Musk has gone even further, imagining features where the chip could record people’s memories so they can reminisce about moments they otherwise may have forgotten.
As for why the FDA denied Neuralink’s application to begin human trials, sources said there were “dozens of issues the company must address.” Some of the FDA’s safety concerns involve the potential for the device’s wires to “migrate” and damage other areas of the brain, potential issues with the lithium battery in the device, and whether a procedure to surgically remove the device would damage a patient’s brain tissue.
Likely furthering those safety concerns are the investigations into Neuralink possibly violating animal welfare laws while attempting to rush development. According to a previous report, also by Reuters, approximately 1,500 monkeys, pigs, and mice have been killed undergoing Neuralink testing since 2018.
“Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon,” a former program director for neural engineering in the U.S. National Institutes of Health (NIH) told Reuters.
As the report lays out, Neuralink formed in 2016, but didn’t apply for approval from the FDA for trials until early 2022, only to have that application denied. Musk appears to have nonetheless been making claims that were impossible to deliver on due to the company not having yet applied for FDA approval, let alone received it.
For example, during a Neuralink presentation in 2019, Musk said the company was looking to be approved for human trials by regulators by the end of 2020. In early 2021, Musk tweeted a reply to a man who was paralyzed in a car accident that Neuralink was in “close communication with the FDA” and the company “might be able to do initial human trials” later that year, even though it hadn’t applied.
But, Musk’s most specific timeline for human trials came just around three months ago.
“We are now confident that the Neuralink device is ready for humans, so timing is a function of working through the FDA approval process,” Musk tweeted.
Then at Neuralink’s “Show and Tell” event that same day, Musk said he could get the implant right now and put a six-month timeframe on when he expects the human trials to begin. There are 90 days left for those trials to begin as promised.
Elon Musk’s Neuralink accused of unsafely transporting infected material
Neuralink is planning to start its first human trails soon, and Elon Musk has said the brain-to-machine interface made by his company will let people stream music directly into their grey matter. meanwhile, Neuralink doesn’t seem capable of even following the most basic guidelines when it comes to treating potentially…
Neuralink Under Investigation for Potential Violation of Animal Welfare Act, Report Says – CNET
Neuralink CEO Elon Musk expects human trials within six months
It’s been six years since Tesla, SpaceX (and now Twitter) CEO Elon Musk co-founded brain-control interfaces (BCI) startup, Neuralink. It’s been three years since the company first demonstrated its “sewing machine-like” implantation robot, two years since the company stuck its technology into the heads of pigs — and just over 19 months since they did the same to primates, an effort that allegedly killed 15 out of 23 test subjects. After a month-long delay in October, Neuralink held its third “show and tell” event on Wednesday where CEO Elon Musk announced, “we think probably in about six months, we should be able to have a Neuralink installed in a human.”
Neuralink has seen tumultuous times in the previous April 2021 status update: The company’s co-founder, Max Hodak, quietly quit just after that event, though he said was still a “huge cheerleader” for Neuralink’s success. That show of confidence was subsequently shattered this past August after Musk reportedly approached Neuralink’s main rival, Synchron, as an investment opportunity.
Earlier in February, Neuralink confirmed that monkeys had died during prototype testing of its BCI implants at the University of California, Davis Primate Center but rejected accusations by the Physicians Committee for Responsible Medicine of animal cruelty. In July, Synchron beat Neuralink to market when doctors at Mount Sinai Hospital in New York successfully installed the company’s inch-and-a-half long device into a person living with ALS. The patient, who has lost their ability to move and communicated independently, should be able to surf the web and send text messages using the device to translate their thoughts into computer commands. That same month, an affair Musk had with a Neuralink executive, who is now pregnant with his twins, also came to light.
Neuralink is still working towards gaining FDA approval for its implant, though the company was awarded the agency’s Breakthrough Device Designation in July 2020. This program allows patients and caregivers more “timely access” to promising treatments and medical devices by fast tracking their development and regulatory testing. As of September, 2022 the FDA has granted that designation to 728 medical devices.
The FDA has also updated its best practices guidance regarding clinical and nonclinical BCI testing in 2021. “The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access,” the agency asserted in its May guidance. “Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life.”
“In many ways it’s like a Fitbit in your skull, with tiny wires,” Musk said of Neuralink’s device during the 2021 livestream event. The device relies on as many as 1,024, 5-micron diameter leads “sewn” into a patient’s grey matter to form connections with the surrounding neurons, providing high-resolution sampling of the brain’s electrical emissions and translating between analog electrical impulses and digital computer code. Theoretically, at least. So far, all Neuralink has accomplished is getting a monkey to play Pong without a joystick.
“We hope to have this in our first humans, which will be people that have severe spinal cord injuries like tetraplegics, quadriplegics, next year, pending FDA [Food and Drug Administration] approval,” Musk told the Wall Street Journal’s CEO Council summit in January.
Developing…
Watch Live: Neuralink Brain Implant ‘Show and Tell’ Update – CNET
Elon Musk’s Neuralink delays show-and-tell event to November 30th
Neuralink has delayed its upcoming “show & tell” event by a month. On Sunday morning, Elon Musk tweeted that the showcase would take place on November 30th, instead of October 31st as was originally announced back in August. Musk did not provide a reason for the delay.
Neuralink show & tell now on Nov 30
— Elon Musk (@elonmusk) October 23, 2022
The last time Neuralink held an event, it showed a monkey playing Pong with its mind. Since then, the company has seen most of its co-founders leave, and rumors circulate that Musk has been contemplating investing in a rival brain chip company. Moreover, the fact that Neuralink has yet to secure regulatory approval from the Food and Drug Administration to begin human trials suggests the company finds itself at an inflection point. Whatever it has to show next month may therefore be critical to its future, so it’s not surprising the company thinks it needs more time to prepare.
Elon Musk’s Neuralink will show brain implant progress at a Halloween show-and-tell
Neuralink is finally ready to share more about its work on brain implants. Elon Musk has revealed that Neuralink will hold a “show & tell” progress event on October 31st. He didn’t provide any clues as to what to expect, but the last big demo involved a monkey playing Pong. It wouldn’t be surprising to see a similar example.
A lot may be riding on this showcase. Neuralink still hasn’t begun human trials, and the Food and Drug Administration hasn’t said how close the company might be to receiving approval. Most of the co-founders have left the company since it was founded six years ago, for that matter. Throw in Fortune‘s unofficial reports of a flawed workplace culture and the event could reflect Neuralink’s overall health.
The timing is apt, at least. The presentation comes just as rumors have swirled that Neuralink has offered to invest in its rival Synchron, which recently completed what appears to be the first endovascular installation of a brain-computer interface in the US. While there’s no guarantee of a deal, an event like this could answer questions about Synchron’s possible involvement.
Neuralink progress update show & tell on October 31 st (Halloween)
— Elon Musk (@elonmusk) August 22, 2022