Neuralink receives FDA approval for first human clinical study, marking a significant milestone

Published May 28th, 2023 - 06:55 GMT
Neuralink receives FDA approval for first human clinical study, marking a significant milestone
Neuralink's initial clinical trials will focus on a select number of patients with paralysis or paraplegia, aiming to restore functionality and provide a significant breakthrough in their quality of life

ALBAWABA - Elon Musk's Neuralink, a brain-implant company, has announced that it has obtained approval from the Food and Drug Administration (FDA) to commence its first-in-human clinical trial. 
While Elon Musk had previously anticipated FDA approval for human trials on multiple occasions since 2019, the company faced setbacks when its application was rejected in early 2022 due to the FDA's concerns regarding the safety of the experimental implant. However, after extensive efforts by the Neuralink team in collaboration with the FDA, this recent approval is seen as a crucial initial step towards leveraging the technology to assist numerous individuals in the future, as stated by Neuralink in a tweet. 

Earlier Neuralink has introduced Gertrude, a pig who has been equipped with a coin-sized computer chip in its brain for a duration of two months. This remarkable demonstration signifies an early stride towards achieving the company's vision of utilizing similar implants to treat human diseases and disorders.

Headquartered in San Francisco and co-founded by Elon Musk in 2016, Neuralink aims to revolutionize healthcare by developing wireless brain-computer interfaces embedded with thousands of electrodes. This groundbreaking technology has the potential to address neurological conditions like Alzheimer's, dementia, spinal cord injuries, and create a synergy between humans and artificial intelligence.

During a webcast, Mr. Musk highlighted the efficacy of implantable devices in resolving various health issues, including memory loss, hearing loss, depression, and insomnia. However, he did not provide a specific timeline for the availability of these treatments, stepping back from previous statements that suggested human trials would commence by the end of the current year.

Neuralink's initial clinical trials will focus on a select number of patients with paralysis or paraplegia, aiming to restore functionality and provide a significant breakthrough in their quality of life, as explained by Dr. Matthew MacDougall, the company's head surgeon.

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