Neuralink’s ‘Blindsight’ Device Receives FDA Breakthrough Designation

Elon Musk’s brain-chip company Neuralink has received the FDA’s “breakthrough device” designation for its experimental vision-restoring implant, Blindsight. 

The designation, announced on Tuesday, September 17, did not specify a timeline for human trials. However, with the device now classified as a “breakthrough device,” it is eligible for expedited review by the FDA, which could accelerate the path to human testing.

In a social media post, Musk claimed that Blindsight could potentially restore sight to individuals who have lost both eyes and their optic nerves. He emphasized that if the visual cortex remains intact, even those blind from birth could regain vision for the first time. 

What is Neuralink’s Blindsight?

Blindsight is an implant that uses a microelectrode array embedded in the brain’s visual cortex. The array stimulates neurons based on input from a camera, with the goal of creating visual phenomena for individuals who are blind. Earlier this year, Musk claimed the device is already working in Monkeys and offers resolution like the ones seen in the early Nintendo Graphics.

Despite the excitement surrounding this announcement, experts like professors Ione Fine and Geoffrey Boynton from the University of Washington expressed skepticism about Neuralink’s Blindsight achieving image resolution that could restore human-like vision.

Other companies such as Second Sight Medical Products ceased operations in 2020 after failing to support its Argus bionic eye technology. Current efforts continue worldwide, including trials of advanced bionic eyes in Australia that have shown promise for patients with genetic blindness.

Neuralink, launched by Musk in 2016, has been developing brain-computer interface technology to treat neurological disorders. The company previously announced plans to use its brain chip to help disabled patients communicate and move by thought alone.

Now that Blindsight appears to represent an improvement in previous efforts, it’s hoped that further improvements will be achieved when Neuralink begins its human trials.