Neuralink Receives FDA Approval for First-in-Human Brain-Implant Clinical Trial

by Adeola Adeyeye
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Neuralink Receives FDA Approval for First-in-Human Brain-Implant Clinical Trial

Elon Musk’s groundbreaking brain-implant company, Neuralink, has achieved a significant milestone as the U.S. Food and Drug Administration (FDA) has approved-in-human clinical trials. This pivotal moment marks a crucial step forward for the company’s vision. The company aims to leverage technology to enhance and potentially cure various conditions. They announced this in a tweet on Thursday night, May 25.


While Neuralink did not provide specific details about the study’s objectives, the FDA’s green light is a significant achievement that Neuralink views as a stepping stone toward helping numerous individuals with their groundbreaking technology. The company’s ultimate goals encompass a wide range of applications, including addressing conditions such as obesity, autism, depression, schizophrenia, and even enabling extraordinary capabilities like web browsing and telepathy through brain implants.

Throughout the development process, Neuralink has utilized macaque monkeys to test their Bluetooth-enabled implantable chips. When inserted into the monkeys’ brains, these chips communicate with computers through a tiny receiver. In a remarkable demonstration of their progress, Neuralink released a video in April 2022. The footage showcased a male macaque named Pager playing the computer game Pong. Pager accomplished this solely by using his mind to move a cursor on the screen without needing a physical joystick.


Elon Musk’s unwavering confidence in the safety of Neuralink’s devices made headlines in late 2022 when he expressed his willingness to have them implanted in his children. However, Neuralink faced FDA rejections in 2022 when attempting to initiate human trials. The FDA raised several concerns that Neuralink must address before approving human trials. These concerns revolved around aspects such as the device’s lithium battery, the potential migration of the implant’s wires within the brain and the safe extraction of the device without causing damage to brain tissue.

With the recent FDA approval, the company has overcome significant hurdles and can proceed with its first-in-human clinical trial. This development opens up new possibilities for the future of neuroscience and the potential to revolutionize the treatment of various conditions. Once fully realized. Furthermore, Neuralink’s groundbreaking technology could bring hope and improve the quality of life of countless individuals.

As Neuralink embarks on this crucial phase of its journey, the world eagerly awaits the outcomes of its pioneering research and the potential benefits it may offer humanity.

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