US brain-computer interface company Neuralink says a US regulator has identified its experimental Blindsight implant, which aims to restore people’s sight, as a “breakthrough device”.

The company, co-founded by Elon Musk in 2016, said on Tuesday that it had received the designation from the US Food and Drug Administration (FDA), which regulates that country’s health products.

To be given the breakthrough tag, medical devices needed to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions”, according to the FDA.

Devices which are accepted as part of the regulator’s breakthrough devices program are supported by “speeding up development, assessment, and review for premarket approval”, including greater access to FDA experts.

Blindsight, which Neuralink has yet to showcase publicly, would “enable even those who have lost both eyes and their optic nerve to see”, Musk wrote on his social media platform X following Neuralink’s announcement.

“Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time,” he said.

“To set expectations correctly, the vision will be at first be low resolution, like Atari graphics, but eventually it has the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like [Star Trek character] Geordi La Forge.”

Blindsight is Neuralink’s second brain implant and was allegedly “working in monkeys” by March 2024, according to Musk.

The company’s first implant, called Telepathy, was first implanted in a human in January, as part of clinical trials to allow people with severe paralysis to operate computers using their thoughts.

Since then, the technology has been used to allow patients to play chess online, design 3D objects, and even play video games.

Vision implants 'remain grainy and imperfect’

Researchers have worked for decades to develop bionic eyes and implants to help people see, but achieving high-quality vision using such devices has remained elusive.

While it remained unclear exactly how Neuralink’s Blindsight would work, Professors Ione Fine and Geoffrey Boynton from the University of Washington wrote in The Conversation in August that the device would likely face issues generating image resolution which matched or exceeded normal human vision.

In their research, the professors simulated images of what a high-resolution cortical implant might achieve, which showed “most of the details of the scene are lost”.

“Some scientists have suggested that by stimulating exactly the right combination of electrodes, it would be possible to produce natural vision,” they wrote.

“Unfortunately, no one has yet suggested a sensible way to determine the receptive field of each individual neuron in a specific blind patient.

“Without that information … vision from cortical implants will remain grainy and imperfect, regardless of the number of electrodes.”

Given the complex challenge of attempting to restore sight, a number of failed devices and defunct companies have left patients with outdated or unsupported implants in their bodies.

American company Second Sight Medical Products stopped providing technical support for its Argus bionic eyes when the firm folded in 2020, leaving some customers feeling vulnerable.

The prothesis were taken over in 2023 by the company Cortigent, which said its Argus II device was “the world’s first FDA-approved device for providing artificial vision”.

In Australia, the first clinical trial of a second-generation bionic eye developed by local company Bionic Vision Technologies allegedly “provided rapid improvements for four patients with blindness caused by the genetic eye condition retinitis pigmentosa”.

The device used an electrode array implanted behind the eye which received signals from a video camera mounted on a pair of glasses.