Revolutionizing Innovation: Neuralink Ready to Embark on Landmark Human Trials, Unveiling the Future of Brain Implants

Neuralink, the biotechnology startup founded by Elon Musk, has started recruiting for its inaugural human clinical trial, according to a recent company blog post. Following approval from an independent review board, Neuralink is preparing to provide brain implants to individuals with paralysis as part of the PRIME Study. This study aims to assess the safety and effectiveness of the Precise Robotically Implanted Brain-Computer Interface (PRIME) implant.

Trial participants will undergo a surgical procedure to implant a chip into the specific area of the brain responsible for controlling movement intentions. This chip will then transmit and record brain signals to a mobile application, with the initial objective of allowing individuals to control a computer cursor or keyboard solely through their thoughts, as stated by the company.

Individuals affected by quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may be eligible to participate in this extensive six-year study. The study involves 18 months of at-home and clinic visits, followed by ongoing follow-up appointments for the subsequent five years. Those interested can register as a patient on Neuralink's website.

Musk has dedicated the past five years to Neuralink's mission of integrating implants to establish a connection between the human brain and a computer. However, the company has only conducted animal testing thus far. In a concerning development, an incident occurred during project testing in 2022, resulting in the death of a monkey that was being trained to play Pong, one of the earliest video games.

In a recent update, Neuralink announced via a tweet that it has obtained FDA clearance for conducting clinical trials on humans. This approval has been officially acknowledged by the agency in a statement. Notably, the initiation of human trials follows a successful fundraising round in which Neuralink raised $280 million. The funding was led by Founders Fund, a San Francisco-based venture capital firm founded by Peter Thiel, a controversial billionaire and co-founder of PayPal.

"We are filled with great anticipation for the upcoming phase at Neuralink," expressed the company on X, the social media platform owned by Musk formerly known as Twitter.

Despite Musk's repeated announcements of human trials at the startup since 2019, the company did not pursue FDA approval until 2022. However, the agency rejected the application due to safety concerns outlined in a March Reuters report. These concerns stemmed from the potential migration of implant components to other areas of the brain and the risk of brain tissue damage upon device removal. In December, during a recruitment event, Musk stated that Neuralink had submitted the majority of required paperwork to the US Food and Drug Administration and could commence human testing within six months.

But employees told Reuters in December that the company is rushing to market, resulting in careless animal deaths and a federal investigation.

Neuralink did not respond to CNNs request for comment.

Neuralinks brain implants require regulatory approval before they can be introduced into the wider market. In 2021, the FDA released a paper outlining its initial insights on brain-computer interface devices, acknowledging the rapid advancement in this field.