California-based Neuralink, a neurotechnology company that is developing implantable brain–computer interfaces, announced on Wednesday that it has gained approval to begin recruitment for its first-in-human clinical trial.
Currently, the company is seeking people with paralysis caused by cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) to test its experimental device in a six-year study.
The Food and Drug Administration denied Neuralink‘s request to fast-track human trials last year.
However, in May the agency approved an investigational device exemption (IDE) for the company, allowing the use of its device for clinical studies. It is unclear how the FDA resolved its initial concerns.
Neuralink: The PRIME Study
According to the company, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention during the study.
Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.
The company says that the initial goal of the BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.
The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023.
Elon Musk unveiled Neuralink in July 2019 as a startup specialising in brain-computer interface (BCI). The premise is simple wherein numerous thin wires can be implanted in a brain to intercept signals being fired by a group of neurons.
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