Neurotechnology startup Neuralink, of which Elon Musk is one of the founders, announced in a statement that it has received approval from the US Food and Drug Administration (FDA) to conduct its first human clinical trial.Neuralink receives critical approval
Neuralink is developing a brain implant called Link that aims to help severely paralyzed patients control external technologies using only neural signals. This means that patients with serious illnesses such as ALS may eventually regain their ability to communicate with loved ones by moving cursors and typing with their minds.
“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 enable our technology to help many people,” the company said in a tweet. The scope of the approved trial is unknown. Neuralink said in a tweet that patient recruitment for the clinical trial is not yet open.
What is Neuralink working on?
Neuralink is part of the emerging brain-computer interface or BCI industry. BCI is a system that decodes brain signals and translates them into commands for external technologies. Neuralink is perhaps the most well-known company in this field, thanks to Musk’s high profile, who is also the CEO of Tesla, SpaceX and Twitter.Scientists have been working on BCI technology for decades, and several companies have developed promising systems they hope to bring to market. But getting FDA approval for a commercial medical device is no small task. Companies are obliged to perform several very comprehensive tests and to successfully provide security issues.
No BCI company has managed to get final approval from the FDA. However, Neuralink is one step closer to market by getting approval for a study with human patients. Neuralink’s device is surgically implanted into patients’ brains. The system centers on Link, a small circular implant that processes and translates neural signals. The link is connected to a series of thin, flexible wires that are inserted directly into the brain tissue, where they sense nerve signals.
Patients with Neuralink devices will learn to control the device using the Neuralink app. According to the company’s website, patients will then be able to control external mice and keyboards via a Bluetooth connection. Experts believe that in addition to helping patients with stroke, BCIs may one day help treat diseases such as blindness and mental illness.
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