Controversial Neuralink Receives FDA Approval for Brain-Chip

Photo edit of Elon Musk and Neuralink. Credit: Alexander J. Williams III/Pop Acta.
Photo edit of Elon Musk and Neuralink. Credit: Alexander J. Williams III/Pop Acta.

Elon Musk’s Neuralink has received FDA approval for its first-in-human clinical study. The neurotechnology startup aims to develop brain-chip implants to treat neurological disorders and enhance human capabilities. The FDA had previously rejected the company’s application over safety concerns. The approval comes as lawmakers request investigations into Neuralink’s animal testing practices. The global market for brain implants is expected to grow significantly, driven by the increasing elderly population and the demand for neurological treatments.

Neuralink and similar brain implants raise concerns about a dystopian future where AI-like technology controls human thoughts. However, it remains uncertain whether these systems can manipulate thoughts or simply act as tools to combat cognitive decline.

Neuralink’s mission is to advance neurotechnology, specifically brain-chip implants, to address neurological disorders and enhance human capabilities. Their primary goal is to create a direct interface between technology and the human brain, enabling treatment of conditions like paralysis and blindness. Additionally, Neuralink aims to unlock the potential for memory preservation and augmentation of human cognition. Ultimately, their objective is to revolutionize neuroscience and provide groundbreaking solutions to enhance the lives of those with neurological conditions.

Neralink would announce their FDA approval to launch their first-in-human clinical study, saying:

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people. Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”

Musk would take to Twitter, saying:

“Congratulations Neuralink team!”

According to the Daily Wire:

Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons, and would allow humans to save and replay memories, saying that “the future is going to be weird.”

Deep brain stimulators, which send electrical impulses through electrodes implanted in the brain, currently occupy the largest market share in the broader brain implant space. Increased awareness of the treatment options for neurological movement disorders is expected to accelerate growth in the sector.

Paradromics, a company seeking to build direct data interfaces with the human brain, earned a breakthrough device designation last week from the FDA, granting the firm an expedited review process to incorporate the technology into medical applications. The company is seeking to develop an implanted brain-computer interface, also called a BCI, that can function outside of a laboratory to assist patients who lose the physical ability to speak or type, such as those impacted by spinal cord injuries and strokes.

Earlier this month, researchers at the University of Texas in Austin unveiled a system that uses AI to transform a person’s brain activity into written words. The “semantic decoder” learns how to translate thoughts as the person listens to podcasts, and the system concurrently measures brain activity, then produces text that mirrors the meaning of the individual’s thoughts. The system does not require implants but is impractical for use outside of a laboratory.

The FDA approval of Neuralink’s first-in-human clinical study is a significant achievement in advancing brain-chip implants for neurological disorders and human enhancement. Overcoming past safety concerns, this milestone opens doors to potential groundbreaking advancements. The market for brain implants is expected to expand due to a growing elderly population and the rising need for effective neurological treatments.

Notify of
Inline Feedbacks
View all comments