Neuralink Blindsight implant gets FDA green light

Neuralink owner Elon Musk says that a new BlindSight device that helps restore peoples sight - even for those who’ve been blind since birth or even those who have ‘lost both eyes and their optic nerve’ - just got a big boost after it received a Breakthrough Device Designation from the US Food and Drug Administration (FDA), which will help speed up its development.

Neuralink kept the details of the new device vague and said it could “bring back sight to those who have lost it” and Musk claimed it could enable “even those who have lost both eyes and their optic nerve to see.”

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

In an X post he said the vision from this device will initially be at “low resolution,” but then claimed it could eventually become better than natural vision and “enable you to see in infrared, ultraviolet or even radar wavelengths,” like some of the cyborg-like implants that I’ve talked about before.

The company has a long way to go before those claims can be proven true or false, but the FDA designation is a boost for Blindsight’s progress to market. The Breakthrough Devices programme aims to give patients and healthcare providers timely access to medical devices by speeding up the development, assessment and review of devices for premarket approval.

This marks another victory for Neuralink, which has been focused on a human trial for a brain-implant device that lets people interact with devices without needing to use of their limbs. Two patients have been implanted with this device so far and the company has shared exciting progress on both of these individuals.

Neuralink received FDA approval last year to run clinical trials on humans, in the form of an investigational device exemption. This allows devices to be used in a clinical study in order to collect “safety and effectiveness data.”

The company has trialled the technology with pigs and monkeys over the years, with one monkey making headlines when it was shown playing the classic video game Pong with its mind. But like many companies associated with Musk, Neuralink has been hit with controversy in the past. The company faced federal investigation in the US for potential animal welfare violations during its trials.