Neuralink Gets Approval For Human Trials

Charles Oladimeji
Elon Musk’s neurotech venture, Neuralink, announced on Thursday that it has received the green light from the Food and Drug Administration (FDA) to commence its first-ever in-human clinical trials.
Neuralink’s Brain Chip Technology. Photo: Steve Jurvetson | Flickr

Founded in 2016 by Elon Musk and a team of seven scientists and engineers, Neuralink is an American neurotechnology company focused on the development of implantable brain-computer interfaces (BCIs). Their flagship product, the Link, is a brain implant designed to enable individuals with severe paralysis to control external technologies using neural signals.

By harnessing the power of neural signals, Neuralink aims to help patients with degenerative diseases like ALS regain the ability to communicate with loved ones by moving cursors and typing solely with their thoughts. Until recently, Neuralink’s testing capabilities were limited to laboratory animals such as monkeys and pigs. However, with the recent approval from the FDA, Neuralink has now gained authorization to conduct trials involving human subjects.

Neuralink’s vision extends to utilizing its microchips to address conditions like paralysis and blindness, as well as assist individuals with disabilities in using computers and mobile technology. The company has developed a computer chip embedded with electrodes, intended to be surgically implanted onto the brain’s surface, akin to a sewing machine used for traditional fabric work. To ensure precise and accurate surgical procedures, Neuralink has also created a robotic device.

Previously, the FDA rejected Neuralink’s application for human clinical trials in 2022 due to significant safety concerns related to the device’s lithium battery, the potential migration of its tiny wires within the brain, and the method of safe removal without damaging brain tissue. However, Neuralink swiftly responded to these concerns, reinforcing the safety measures and emphasizing the benefits of the brain-chip technology, along with the steps taken to reduce and prevent potential risks.

Elon Musk discussing at a Neuralink Conference. Photo: ApolitikNow | Flickr

On May 25th, 2023, Neuralink took to Twitter to share an exciting update: they have received FDA approval to initiate their inaugural clinical study involving human participants. The achievement is the culmination of remarkable efforts by the Neuralink team, working closely with the FDA. This milestone represents an important initial stride towards the future potential of their technology in aiding numerous individuals.

While the recruitment process for the clinical trial has not yet commenced, Neuralink assures that further details will be announced in the near future.
Despite the FDA approval for human testing, Neuralink can anticipate rigorous scrutiny to ensure the safety and reliability of their devices. Additionally, ethical and security concerns arise due to the potential cognitive advantages conferred by implant technology.

Clinical Trials in Humans 

The Neuralink Team. Photo: Steve Jurvetson | Flickr

Neuralink has yet to disclose the specific date when the clinical trials involving human participants will commence, but an announcement is expected from the company in the following weeks. According to information provided in a patient registry on Neuralink’s website, only individuals with specific conditions such as paralysis, blindness, deafness, or speech impairment will be eligible to participate in the trials. This huge progress in human testing brings Elon Musk’s vision of human-AI hybrids closer to reality.

As a result, developers and entrepreneurs are encouraged to explore potential applications and use cases for a surgically implanted brain-computer interface (BCI) for recreational purposes. Musk has also suggested that BCIs could enable people to operate smartphones faster using their brain waves compared to their thumbs. The potential of Neuralink’s brain chip presents an exciting prospect in the technology industry, sparking anticipation for future advancements and applications.

Let us know your thoughts about the FDA’s approval of Neuralink’s brain chip testing in humans.


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