FDA approves Elon Musk's Blindsight, a device that allows blind people to see the outside world

The US Food and Drug Administration (FDA) designated Elon Musk's brain chip startup Neuralink's experimental implant, named Blindsight, as a "breakthrough device" on Thursday, September 19, 2024.

Medical devices that aim to cure or diagnose life-threatening illnesses are granted this designation, which also serves to expedite their development and review.

According to Musk's X post, blindsight is the ability for persons who have lost both their eyes and optic nerves to see again.

Neuralink hasn't disclosed the start date of the human studies, though.

Blindsight, which debuted in the New York Post, has been granted authorization by the US Food and Drug Administration to take part in the volunteer program. The FDA reports that this is one of the 58 devices that have been granted this designation this year.

"Those who have lost both eyes and their optic nerves will be able to see again thanks to Neuralink's Blindsight device," Musk wrote on Tuesday in X, as reported by NYPost on Saturday, 21/9.

Musk stated that even if someone has been blind since birth, sight can still be restored as long as the visual brain is still functional.

According to the agency's website, this "breakthrough device" program seeks to "accelerate development, assessment and review for pre-market approval" for medical devices that treat permanent or life-threatening illnesses, provided that they comply with safety criteria.

"To set expectations correctly, vision will initially be low resolution, like Atari graphics, but eventually have the potential to be better than natural vision and allow you to see in infrared, ultraviolet, or even radar wavelengths, like Geordi La Forge," Musk stated.

The FDA representative stated that the designation "does not mean the device is deemed safe and effective or marketable for medical purposes" in response to a question.

"For life-threatening conditions or permanently debilitating human diseases or conditions, the FDA only evaluates whether there is a reasonable expectation that a device can provide more effective treatment or diagnosis compared with the current US standard of care, and if the device represents a new technology and there are no other legally marketed alternatives," the spokesperson continued.

Neuralink was reportedly founded in 2016. Additionally, this company is working on an implant that will allow people who are paralyzed to control digital gadgets with their minds. (*)