Neuralink, the neurotechnology startup co-founded by Elon Musk, announced Thursday that it has received approval from the US Food and Drug Administration for its first human study.
Neuralink is implanting a chip called Link into the brain, which aims to help severely paralyzed patients control external technologies using only neural signals. This means that patients with diseases as numerous as ALS can finally regain their ability to communicate with their loved ones by moving cursors and writing through their “minds.”
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!— Neuralink (@neuralink) May 25, 2023
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…
Patients with Neuralink devices will learn to control them using the Neuralink app, and patients will then be able to control external mice and keyboards through a Bluetooth connection, according to the company’s website.
The US Food and Drug Administration’s approval of a human study is an important step for Neuralink after a series of hurdles the company has faced recently.
In February, the US Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink over allegations that contaminated hardware was unsafely packaged and transported. Reuters reported in March that the US Food and Drug Administration had denied Neuralink’s request for human trials.