Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.
No BCI company has managed to clinch the FDA's final seal of approval. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market.
Neuralink's BCI will require patients to undergo invasive brain surgery. Its system centers around the Link, a small circular implant that processes and translates neural signals. The Link is connected to a series of thin, flexible threads inserted directly into the brain tissue where they detect neural signals.
Patients with Neuralink devices will learn to control it using the Neuralink app. Patients will then be able to control external mice and keyboards through a Bluetooth connection, according to theThe FDA's approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company. In February, the U.S.
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