Caleb Naysmith | BENZINGA
Elon Musk, the genius behind SpaceX and Tesla Inc., has declared that humanity must embrace the merging of man and machine if we hope to survive in a world dominated by artificial intelligence (AI).
In a 2018 appearance on the "Joe Rogan Experience," Musk teased his company Neuralink has something exciting in store for us. He believes his technology will allow humans to achieve a state of "symbiosis" with AI, where we’ll be able to effortlessly combine our brains with computers. Neuralink has been developing brain implants since 2016 with the goal of curing conditions like paralysis and blindness.
Brain Technology & Artificial Intelligence
Brain-Tech has been big business as of late. Synchron recently raised $75 million from the likes of Bill Gates and Jeff Bezos, and venture-backed TruBrain launched a community round, which means anyone can invest, and seen significant traction among venture capital and retail investors over the years.
According to Musk, people's attachment to their phones already makes them cyborgs, but everyone could still be smarter. The reason is that the information flow between the biological and digital self is painfully slow. Neuralink’s brain-machine interfaces aim to change that by creating a direct communication pathway between the human brain and computers. This technology could eventually allow humans to upload themselves into new units if their biological selves die, essentially achieving immortality.
Musk believes that by merging with AI, humans will be able to keep up with the rapid advancements in technology and compete against AI. He argues that rather than trying to beat machines, humans should join them. Neuralink’s ultimate goal is to create a world where humans and AI work together in harmony, augmenting each other’s abilities and achieving more than people can on their own.
In addition to developing brain implants for individuals with paralysis and blindness, Neuralink is also working on devices to help people with Parkinson’s disease and other neurological conditions. The company’s ultimate goal is to create a technology that can seamlessly interface with the human brain to treat a range of ailments.
According to Neuralink’s website, the company’s technology has the potential to “restore limb functionality for patients with paralysis due to spinal cord injury or stroke, enable communication for individuals who have lost the ability to speak or gesture and improve the lives of those living with debilitating brain and spinal cord disorders.”
Neuralink is said to have approached one of the largest neurosurgery centers in the U.S. for potential clinical trials collaboration as it gears up to test its devices on humans once regulatory approval is granted.
Setbacks
But the firm had a setback early last year when the U.S. Food and Drug Administration (FDA) denied its request to advance to human trials citing major safety concerns. The FDA allegedly provided Neuralink with a detailed list of concerns that must be addressed before the company can proceed with human testing, which is a crucial step toward obtaining final approval for its product.
The agency's major concerns centered around the device’s lithium battery, the possibility that the implant’s tiny wires could migrate to other parts of the brain and the risks associated with removing the device without damaging brain tissue. Musk predicts that the company will receive FDA approval for human trials in the spring, but some Neuralink staffers remain skeptical that the issues can be resolved quickly.
To assist with the human trials, Neuralink has reportedly engaged in talks with Barrow Neurological Institute, a Phoenix-based neurological disease treatment and research center. While discussions have been held with other centers, the sources, who have chosen to remain anonymous, warned that a collaboration is not guaranteed.
As Neuralink faces setbacks in its quest to conduct human trials for its brain implants, its competitor Synchron has made strides in developing similar technology.
Synchron recently implanted its first device in the brain of a patient with amyotrophic lateral sclerosis (ALS), a debilitating neurodegenerative disease that affects the patient’s ability to move and speak, as reported by Bloomberg.
Despite Musk’s ambitious goals with Neuralink, he and other key figures in artificial intelligence have expressed concerns about the potential risks associated with AI. In fact, they have signed an open letter calling for the suspension of training powerful AI systems because of fears of a threat to humanity.
While Musk believes that merging with AI is necessary for humanity’s survival, he also recognizes the potential dangers that must be addressed.
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Elon Musk's Neuralink wins FDA approval for human study of brain implants
Rachael Levy | REUTERS
May 25 (Reuters) - Elon Musk's Neuralink received U.S. Food and Drug Administration (FDA) clearance for its first-in-human clinical trial, a critical milestone for the brain-implant startup as it faces U.S. probes over its handling of animal experiments.
The FDA approval "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet on Thursday, without disclosing details of the planned study. It added it is not recruiting for the trial yet and said more details would be available soon.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
— Neuralink (@neuralink) May 25, 2023
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
The FDA acknowledged in a statement that the agency cleared Neuralink to use its brain implant and surgical robot for trials on patients but declined to provide more details.
Neuralink and Musk did not respond to Reuters requests for comment.
The critical milestone comes as Neuralink faces federal scrutiny following Reuters reports about the company's animal experiments.
Neuralink employees told Reuters last year that the company was rushing and botching surgeries on monkeys, pigs and sheep, resulting in more animal deaths than necessary, as Musk pressured staff to receive FDA approval. The animal experiments produced data intended to support the company's application for human trials, the sources said.
In one instance in 2021, the company implanted 25 out of 60 pigs with the wrong-sized devices. All the pigs were subsequently killed - an error that employees said could have been easily avoided with more preparation.
In May, U.S. lawmakers urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments after Reuters reported on potential financial conflicts on the panel.
The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the U.S. Department of Agriculture's Office of Inspector General for potential animal-welfare violations. This probe has been looking at the USDA's oversight of Neuralink.
The probe was launched amid growing employee concern that the company is rushing experiments, causing additional suffering and deaths of pigs, sheep and monkeys.
Neither Musk nor Neuralink ever responded to multiple requests for comment on the Reuters reports.
As of several weeks ago, the FDA had not inspected Neuralink over its laboratory practices, according to FDA records and a Neuralink employee.
Victor Krauthamer, an adjunct biomedical engineering professor who spent three decades at the FDA, including a stint overseeing the office that reviews human-trial requests for brain implants, said the FDA does not typically inspect facilities as part of their review of applications for clinical trials. But he added this would have been warranted in this case, given the concerns around Neuralink's animal experiments.
"If the animal testing is unreliable, then (human trial) approval may be based on flawed animal safety data. The FDA should have verified their trust of animal study results," Krauthamer said.
SEVERAL PREDICTIONS
Neuralink had hoped to receive approval to implant its device in 10 patients, Reuters has reported. But more recently, the company was negotiating a lower number of patients with the agency after it raised safety concerns, current and former employees said. It is not known how many patients the FDA ultimately approved.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling Web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices' safety that he would be willing to implant them in his children.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company sought FDA approval only in early 2022, and the agency rejected the application, Reuters reported in March.
See: U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks
The FDA had pointed out several safety concerns to Neuralink that needed to be addressed before sanctioning human trials, Reuters reported. Some of the issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
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