FILE PHOTO: Neuralink said its experimental implant aimed at restoring vision received the U.S. FDA’s “breakthrough device” designation.
| Photo Credit: Reuters

Elon Musk’s brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration’s “breakthrough device” designation.

The FDA’s breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up development and review of devices currently under development.

The experimental device, known as Blindsight, “will enable even those who have lost both eyes and their optic nerve to see,” Musk said in a post on X.

Neuralink did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for comment.

Founded in 2016 by Musk and a group of engineers, Neuralink is building a brain chip interface that can be implanted within the skull, which it says could eventually help disabled patients to move and communicate again, and also restore vision.

Neuralink’s device has a chip that processes and transmits neural signals that could be transmitted to devices like a computer or a phone.

The startup is separately testing an implant designed to give paralyzed patients the ability to use digital devices by thinking alone, a prospect that could help people with spinal cord injuries.

This trial is expected to enroll three patients to evaluate its device in a study expected to take several years to complete, according to details on the U.S. government’s clinical trials database.

Earlier this year, Neuralink successfully implanted the device in the second patient, who has been using it to play video games and learn how to design 3D objects.

Musk has grand ambitions for Neuralink, saying it would facilitate speedy surgical insertions of its chip devices. (File)
| Photo Credit: REUTERS

Billionaire entrepreneur Elon Musk’s brain-chip startup Neuralink said on Tuesday it has received approval from an independent review board to begin recruitment for the first human trial of its brain implant for paralysis patients.

Those with paralysis due to cervical spinal cord injury or amyotrophic lateral sclerosis may qualify for the study, it said, but did not reveal how many participants would be enrolled in the trial, which will take about six years to complete.

The study will use a robot to surgically place a brain-computer interface (BCI) implant in a region of the brain that controls the intention to move, Neuralink said, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.

The company, which had earlier hoped to receive approval to implant its device in 10 patients, was negotiating a lower number of patients with the U.S. Food and Drug Administration (FDA) after the agency raised safety concerns, according to current and former employees. It is not known how many patients the FDA ultimately approved.

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Musk has grand ambitions for Neuralink, saying it would facilitate speedy surgical insertions of its chip devices to treat conditions like obesity, autism, depression and schizophrenia.

In May, the company said it had received clearance from the FDA for its first-in-human clinical trial, when it was already under federal scrutiny for its handling of animal testing.

Even if the BCI device proves to be safe for human use, it would still potentially take more than a decade for the startup to secure commercial use clearance for it, according to experts