Elon Musk’s company, Neuralink, has obtained approval from the Food and Drug Administration (FDA) for its inaugural human clinical study. The neurotechnology firm, founded by Musk in 2016, aims to develop brain implants to assist paralyzed individuals in regaining mobility and address various neurological issues.
In a recent tweet, the company said,
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! 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 technology to help many people.”
Despite Musk’s predictions since 2019 regarding FDA approval, Neuralink faced a setback in early 2022 when its application was rejected. The company has been addressing FDA safety concerns related to the brain implant. Recruitment for the clinical trial has not commenced, but details on participant enrollment will be disclosed shortly.
Neuralink’s mission involves creating a chip enabling the brain to control intricate electronic devices, potentially restoring motor function in paralyzed individuals. The technology merges artificial intelligence with human capabilities, with Musk expressing hope for its application in treating conditions such as Parkinson’s, dementia, and Alzheimer’s.
The first human to receive a Neuralink cybernetic implant is recovering well
Billionaire CEO Elon Musk announced on January 28, 2024, that the first human to receive a Neuralink cybernetic implant is recovering well. Neuralink had initiated open recruitment in September for its first-in-human clinical trial, named the Precise Robotically Implanted Brain-Computer Interface (PRIME) study.
The trial aims to assess the safety of Neuralink’s implant (N1) and surgical robot (R1), evaluating the device’s potential to enable paralyzed individuals to control external devices using their thoughts. He posted,
“The first human received an implant from @Neuralink yesterday and is recovering well,” Musk tweeted on his social media platform X. “Initial results show promising neuron spike detection.”
This version allows users to control their phone, computer, and various devices through thought. Musk emphasized,
“Initial users will be those who have lost the use of their limbs…Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal.”
Stephen Hawking, the late theoretical physicist, battled Lou Gehrig’s disease, resulting in paralysis.
Musk also revealed,
“The first @Neuralink product is called Telepathy”
Neuralink received FDA approval in May to proceed with human trials, following previous setbacks in 2022 when the FDA rejected the company’s application. Musk’s Neuralink, founded in 2016, aims to develop a brain chip that combines artificial intelligence with human capabilities, with the potential to treat conditions such as Parkinson’s, dementia, and Alzheimer’s by restoring motor function in paralyzed individuals.
Previous developments
Back in 2020, Elon Musk announced that Neuralink’s wireless brain implant device, intended to assist disabled patients in movement and communication, is set to enter human clinical trials in six months.
The company, which Musk founded in 2016, has been conducting animal tests while awaiting regulatory approval for human trials. Musk expressed caution, emphasizing the need to ensure the device’s efficacy before human implementation. Neuralink’s last public presentation in April 2021 featured a monkey playing a computer game using a brain-implanted chip.
Originally aiming for regulatory approval in 2020, Neuralink faced delays, with Musk now confident in the device’s readiness pending FDA approval. Musk’s vision involves the brain chip combining artificial intelligence with human capabilities, potentially treating conditions like Parkinson’s, dementia, and Alzheimer’s by restoring motor function in paralyzed individuals.
Despite internal deadline challenges, Neuralink’s competitor, Synchron, received FDA approval in 2021 and successfully implanted its device in a U.S. patient. In contrast, Musk reportedly explored investment opportunities with Synchron earlier this year due to frustrations with Neuralink’s progress.
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