Billionaire entrepreneur Elon Musk's brain-chip startup, Neuralink, has been granted approval by an independent review board to begin recruiting participants for the first human trial of its brain implant designed for paralysis patients.
Individuals with paralysis caused by cervical spinal cord injury or amyotrophic lateral sclerosis may be eligible for the study. The trial is expected to span approximately six years.
However, the number of participants to be enrolled in the trial has not been disclosed.
Neuralink plans to utilise a robot for the surgical placement of a brain-computer interface (BCI) implant, in the brain region responsible for controlling movement intentions.
The primary objective of the study is to enable individuals to control a computer cursor or keyboard solely through their thoughts.
Initially, Neuralink aimed to obtain approval for implanting its device in 10 patients. However, due to safety concerns raised by the United States Food and Drug Administration (FDA), the company has been in negotiations to reduce the number of patients involved.
The FDA's final approval regarding the number of patients remains undisclosed.
Neuralink, led by Musk, has ambitious plans to revolutionise medical treatment by offering fast surgical insertions of chip devices.
These devices are intended to address various conditions such as obesity, autism, depression, and schizophrenia.
In May, Neuralink announced that it had obtained FDA clearance for its first in-human clinical trial.
However, the company was already facing scrutiny from federal authorities regarding its handling of animal testing.
Experts suggest that even if the BCI device proves to be safe for human use, it could take more than a decade for Neuralink to obtain commercial use clearance.
This timeline highlights the complex regulatory process involved in bringing such innovative technologies to market.
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