Neuralink Announces FDA Approval of In-Human Clinical Study (cnbc.com) 56
Neuralink, a neurotech startup co-founded by Elon Musk, has received FDA approval for its first in-human clinical study to test its brain implant called the Link. The implant aims to help patients with severe paralysis regain the ability to control external technologies using neural signals, potentially allowing them to communicate through mind-controlled cursors and typing. CNBC reports: "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," the company wrote in a tweet. The FDA and Neuralink did not immediately respond to CNBC's request for comment. The extent of the approved trial is not known. Neuralink said in a tweet that patient recruitment for its clinical trial is not open yet.
No [brain-computer interface, or 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 the company's website.
No [brain-computer interface, or 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 the company's website.