Neuralink billionaire founder Elon Musk posted on X on Monday that on Sunday, Neuralink completed the world's first human trial, the human implantation of a brain chip, and patients are now recovering well. "Preliminary results show that neuronal spike detection is promising. Musk added.
Spikes are the activity of neurons, which the National Institutes of Health describes as cells that use electrical and chemical signals to send messages around the brain and to the body.
The startup's Prime study is a trial of its wireless brain-computer interface to evaluate the safety of implants and surgical robots.
According to the company**, the study will evaluate the functionality of the interface, which enables people with quadriplegia or quadriplegia to control devices with their thoughts.
Other than that, Neuralink did not provide further details.
Reuters reported earlier this month that Neuralink was fined for violating U.S. Department of Transportation (DOT) regulations on the transportation of hazardous materials.
During an inspection of the company's facilities in Texas and California in February 2023, Department of Transportation investigators found that the company failed to register itself as a hazardous materials hauler, according to agency records.
They also found that hazardous waste was improperly packaged, including a flammable liquid xylene. According to the U.S. Centers for Disease Control and Prevention, xylene can cause headaches, dizziness, confusion, loss of muscle coordination, and even death.
Last May, the U.S. Food and Drug Administration (FDA) approved the company for a first-in-human implant trial last year. This is a major milestone for the startup. Reuters reported in June that the company was valued at as much as $5 billion.
In September last year, Neuralink announced a program for implant trials. Over the course of the study, the company said the robot it developed will surgically implant "ultra-thin" wires to help transmit signals in the participants' brains.
Elon Musk's brain-implant startup Neuralink says it has received approval from an independent review committee to begin recruiting patients for first-in-human trials. The company is looking for paralyzed patients to test its experimental setup for a six-year study.
Neuralink is one of several companies developing brain-computer interfaces (BCIs) that collect and analyze brain signals. But its billionaire executives' exaggerated claims about the company, including a promise to develop an all-encompassing brain computer to help humans keep up with artificial intelligence, have raised skepticism and ethical concerns among neuroscientists and other experts.
Last year, the U.S. Food and Drug Administration rejected the company's request to fast-track human trials, but in May 2023 it granted Neuralink's investigational device exemption (IDE), allowing the device to be used in clinical studies. The agency has not revealed how its initial concerns were addressed.
Neuralink continues to look for patients with quadriplegia due to vertical spinal cord injury or ALS. Participants will surgically implant a brain-computer interface into an area of the brain that controls movement using a proprietary robot, with the goal of enabling them to control a computer cursor or keyboard using only their minds.
The company's announcement comes months after it received regulatory approval to conduct trials. There have been reports of unnecessary suffering caused by the trials, and previous animal tests are still under review. Former employees described the test as "hacking work" and told Reuters that on one occasion the device was implanted in the wrong place in a test pig, resulting in pigs being euthanized.
The allegations have sparked multiple investigations, including an investigation by the Department of Agriculture into animal cruelty and an investigation by the Department of Transportation into the mishandling of biohazardous materials across state lines.
The company did not immediately respond to inquiries about when and where the trial will take place or how many participants will be involved. If its device proves safe for human use, it may be decades before it is approved for use in patients outside of trials.
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