[Bloomberg] Musk’s Neuralink Hopes to Implant Computer in Human Brain in Six Months

I followed them closely initially. Very cool stuff. Been waiting for something. Actual human medical trials and results from that would tell us quite a bit about how practical this is in the short term.

Either way, Musk is going to love the FDA if approved and talk up a story of how great it is or attack the FDA as outdated and irrelevant if he disagrees with their decision or requirements.

 

I can just see this ****. There I am driving down the road and all of a sudden an ad comes on and tries to shut down my brain. I'm yelling "Skip ad! Skip ad!"

Elon: "Should have paid for the ad free version"

 

“Extreme Suffering”: 15 of 23 Monkeys with Elon Musk’s Neuralink Brain Chips Reportedly Died

 

At that point, what would be the use of ads? You could just enslave people

 

There's a lot of players in this field already so it's going to happen sooner or later. Probably sooner whether it's by Neuralink or someone else. I think this technology is pretty much inevitable.

 

The 6M milestone is soon, but given their past performance, it's highly unlikely they'll achieve it. It appears that they've been addressing safety concerns following the FDA's rejection of their human trials in 2022.


U.S. regulators rejected Elon Musk’s bid to test brain chips in humans (reuters.com)

On at least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness.

Yet the company, founded in 2016, didn’t seek permission from the U.S. Food and Drug Administration (FDA) until early 2022 – and the agency rejected the application, seven current and former employees told Reuters.

The rejection has not been previously reported. In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path to final product approval, the staffers said. The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said.

...

Such FDA rejections do not mean a company will ultimately fail to gain the agency’s human-testing approval. But the agency’s pushback signals substantial concerns, according to more than a dozen experts in FDA device-approval processes.

...

Safety concerns

The FDA’s rejection listed dozens of what the agency calls “deficiencies” that the company must address before human trials, five Neuralink sources said. They called some issues relatively minor.

One serious FDA concern involved the possibility that the device’s tiny threads, which carry electrodes, could migrate to other areas of the brain, according to six current and former employees. The company has sought to address the issue through animal tests on dozens more pigs, three Neuralink sources said.

Migrating wires can induce inflammation, impair function in critical areas of the brain and rupture blood vessels, said Victor Krauthamer, a former FDA official for three decades, including a stint as acting director of the office that reviews human-trial requests for brain implants. A migration problem can also erode the device’s effectiveness, leading to the risk of surgical removal, he and other experts said.

“The threads can cause damage because brains are very, very soft and very delicate,” Krauthamer said.

The FDA’s concerns about the battery are also potentially serious, experts in brain devices said. Neuralink proposed making its device with a novel charging system involving lithium batteries that could be recharged remotely. The agency found the company needed to show in animal studies that the battery was very unlikely to fail, six current and former Neuralink employees said. If any component of the device that is connected to the battery current fails, the current could potentially damage brain tissue, three brain-implant experts said.

The FDA also raised questions about whether the device could be removed without damaging brain tissue. In Neuralink’s November presentation, officials acknowledged the FDA concern but downplayed it.

Engineer Alex Wood-Thomas was asked about the potential danger of removing the device in order to implant an upgraded one in the future. He responded that, because of the threads’ small size, scarring “within the brain is so minimal that they're actually removed quite easily.”

Several employees disputed his characterization as misleading and unsupported by animal studies, according to two Neuralink sources and internal discussions seen by Reuters.

Wood-Thomas declined to comment.

The FDA also flagged concerns that the device could overheat, also potentially damaging tissue.

Neuralink may be able to address all of the FDA’s concerns, industry and regulatory experts said.

If the FDA has lingering minor issues with a company’s device, it might let the firm move forward with a slower, staged trial, the experts said. The agency has suggested such a path might work for Neuralink, with fewer subjects implanted at first, and more tested months later, according to two people familiar with the discussions. Still, that proposal disappointed Neuralink because it could delay progress toward final FDA approval, one of the sources said.

Neuralink is hardly alone among brain-implant pioneers in slogging through difficult research and regulatory challenges that can drag on for years, said Gene Civillico, a neurophysiologist who formerly worked for both the FDA and the NIH on neural-implant research.

“The reason we don’t have a (BCI) device yet like Neuralink’s is not because no one has spent any money on it,” Civillico said. “It’s not because Elon Musk hasn’t thought about it enough. It’s because it’s a hard problem.”

....


Musk's missed deadlines for FDA approval of Neuralink

July 2019:Musk says Neuralink is aiming to receive regulatory approval for human trials of brain implants by the end of 2020.

February 2021: Musk tweets: “Neuralink is working super hard to ensure implant safety & is in close communication with the FDA. If things go well, we might be able to do initial human trials later this year.”

April 2022: Musk tells an interviewer that “aspirationally” the company aims to get FDA approval to “do the first human implant this year.”

November 2022: Musk tweets: “We are now confident that the Neuralink device is ready for humans, so timing is a function of working through the FDA approval process.” He says at Neuralink’s “show-and-tell” that he expects the device to be in humans in six months, and that he considers it safe enough for his own children.

 

I'm surprised it would start with a direct link to the brain given they can control fingers currently with a helmet. It might not be needed as the chips might be able to function outside the skull

 

As I said there are already many players in this field and one more unscrupulous than others. There are already experiments on direct brain connections so if someone can find success that likely will happen. Chances are there are people who would willing volunteer to have electrodes implanted if it would allow them a direct neural link.

 

I have mixed feelings about this. This technology like so much new technology will likely change humanity for both the good and the bad. As much as it could help paralyzed people move it could also lead to far intrusion into body autonomy. Imagine the contracts were locked into for our phones. Now
Imagine those for something implanted in our bodies with direct link to our brains.

This technology is already happening and like AI, nanotechnology, genomics there is going to be a large race to get it to market.

 

I'm glad they're not rushing this project like they did with vaccines.
______

The Gruesome Story of How Neuralink’s Monkeys Actually Died

https://www.wired.com/story/elon-musk-pcrm-neuralink-monkey-deaths/

 

Exciting time…

https://neurosciencenews.com/neuralink-human-implant-22542/


Key Facts:

1. First Human Implant: Neuralink achieved a major breakthrough by successfully implanting its brain-computer interface in a human patient.
2. Targeted Participants: The clinical trial focuses on patients with quadriplegia and amyotrophic lateral sclerosis (ALS) aged 22 and above, offering hope for those with severe movement impairments.
3. Wireless Brain-Computer Interface: Neuralink’s technology aims to empower individuals to control devices using their thoughts, potentially revolutionizing the lives of people with paralysis.

 

Elon decided the phrase "having a couple of screws loose" needed a reboot.

UC Davis veterinary records cited by the Physicians Committee—which WIRED also obtained through a subsequent California public records request—chronicle a battery of complications that developed following procedures involving electrodes being surgically implanted into monkeys’ brains. The complications include bloody diarrhea, partial paralysis, and cerebral edema, a condition colloquially known as “brain swelling.”

For example, in an experimental surgery that took place in December 2019, performed to determine the “survivability” of an implant, an internal part of the device “broke off” while being implanted. Overnight, researchers observed the monkey, identified only as “Animal 20” by UC Davis, scratching at the surgical site, which emitted a bloody discharge, and yanking on a connector that eventually dislodged part of the device. A surgery to repair the issue was carried out the following day, yet fungal and bacterial infections took root. Vet records note that neither infection was likely to be cleared, in part because the implant was covering the infected area. The monkey was euthanized on January 6, 2020.

Additional veterinary reports show the condition of a female monkey called “Animal 15” during the months leading up to her death in March 2019. Days after her implant surgery, she began to press her head against the floor for no apparent reason; a symptom of pain or infection, the records say. Staff observed that though she was uncomfortable, picking and pulling at her implant until it bled, she would often lie at the foot of her cage and spend time holding hands with her roommate.

Animal 15 began to lose coordination, and staff observed that she would shake uncontrollably when she saw lab workers. Her condition deteriorated for months until the staff finally euthanized her. A necropsy report indicates that she had bleeding in her brain and that the Neuralink implants left parts of her cerebral cortex “focally tattered.”

Yet another monkey, Animal 22, was euthanized in March 2020 after his cranial implant became loose. A necropsy report revealed that two of the screws securing the implant to the skull loosened to the extent that they “could easily be lifted out.” The necropsy for Animal 22 clearly states that “the failure of this implant can be considered purely mechanical and not exacerbated by infection.” If true, this would appear to directly contradict Musk’s statement that no monkeys died as a result of Neuralink’s chips.

​

Something tells me Elon's dream of going to space involves being That Alien who abducts local rednecks and performing anal probes for The Science.