Neuralink gets breakthrough tag for sight-restoring implant

Elon Musk's Neuralink has been awarded breakthrough status from the FDA for an implantable chip – dubbed Blindsight – that promises to restore the sight of people with vision impairment.

There's little information on the product yet and, as is often the case with Neuralink developments, the main source of news is Elon Musk himself via his X.com platform (formerly Twitter).

In a post, the tech billionaire claimed Blindsight "will enable even those who have lost both eyes and their optic nerve to see", although, he tempered expectations by noting that, initially at least, it will be "low resolution, like Atari graphics."

If the patient's visual cortex is intact, "it will even enable those who have been blind from birth to see for the first time," according to Musk, who suggests that in time Blindsight could enter the realms of science fiction by enhancing vision so users can see in "infrared, ultraviolet, or even radar wavelengths."

There's no information yet on when Blindsight may be ready for human trials, but having breakthrough status from the FDA means there will be closer interaction with the regulator during the premarket review phase and a prioritised review if it reaches that stage.

Earlier this year, Neuralink said it had implanted its wireless brain-computer interface (BCI) device into a human being for the first time, following FDA approval of clinical trials last year, with a second volunteer receiving one in July.

The implant relies on the use of 64 micron-scale threads that are inserted into areas of the brain that control movement or receive sensory information, with each thread containing multiple electrodes that can detect neural signals.

Neuralink is currently seeking additional volunteers for its PRIME study, which is designed to show that the implant is safe and useful in daily life and can help to interact with digital technologies.

In a recent blog post, Neuralink said the second recipient – a quadriplegic due to a spinal injury – had been able to improve his ability to play video games and had been learning how to use computer-aided design (CAD) software with the help of the implant. It reported that it took less than five minutes for the subject – called Alex – to start controlling a cursor on a computer with his mind.

The company also said that there had been some evidence of 'thread retraction' with the first recipient, called Noland, but that this had now stabilised and the performance of the implant had recovered. So far, there has been no thread retraction with Alex.

While Musk's association with Neuralink means the company's developments tend to hit the headlines, other companies are working on BCI technologies, including Blackrock Neurotech – which has implanted dozens of implants into patients – as well as Paradromics and Synchron.

Photo by Amber Weir on Unsplash