Elon Musk’s Neuralink received approval to launch a new feasibility trial using its brain implant and an investigational assistive robotic arm, the brain-chip startup said in a post on X on Monday.
Neuralink is conducting its PRIME study, aimed at evaluating the safety of its wireless brain-computer interface and surgical robot. It is assessing the initial effect of the implant in patients with quadriplegia, a form of paralysis, to control external devices with their thoughts.
The company plans to cross-enroll participants in the feasibility study from the ongoing PRIME trial, it said in a post on social media platform X.
The Food and Drug Administration and Neuralink did not immediately respond to requests for details on the feasibility study.
Last week, the company received approval from regulator Health Canada to launch a trial of its device in Canada. Canadian neurosurgeons in partnership with the startup have regulatory approval to recruit six patients with paralysis in the study.
In the United States, Neuralink has already implanted the device in two patients. It has allowed the first patient to play video games, browse the internet, post on social media and move a cursor on his laptop.
The company has said its device is working well in the second trial patient, who has been using it to play video games and learn how to design 3D objects.
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