Neuralink, Elon Musk’s brain chip company, has been granted “breakthrough device” status by the FDA for an implant designed to help blind individuals regain their sight, the company revealed.
The device, named “Blindsight,” has been cleared to participate in the FDA's voluntary program, which accelerates the development and approval process for innovative medical devices. According to the FDA, it is one of 58 devices to receive this designation so far this year.
Musk, known for making ambitious predictions about his companies' products well before they reach the market, celebrated the news by sharing a photo of LeVar Burton, who portrayed Geordi La Forge in "Star Trek: The Next Generation." La Forge’s character used advanced technology to gain vision through a futuristic visor.
"The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” Musk wrote on X (formerly Twitter). “As long as the visual cortex is intact, it will even allow those born blind to see for the first time.”
The FDA’s “breakthrough device” program is designed to “accelerate development, evaluation, and review for premarket approval” for medical devices treating life-threatening or permanent conditions, provided they meet safety standards, according to the agency.
“To set expectations, the vision will initially be low resolution, like Atari graphics, but it has the potential to eventually surpass natural vision, allowing users to see in infrared, ultraviolet, or even radar wavelengths, similar to Geordi La Forge,” Musk added.
An FDA spokesperson clarified that the breakthrough status does not indicate the device has been approved for safety or effectiveness, nor that it can be marketed for medical use.
“The FDA evaluates whether there is a reasonable expectation that a device could offer more effective treatment or diagnosis compared to the current U.S. standard of care, particularly for life-threatening or irreversible conditions, and if the device represents novel technology with no existing market alternative,” the spokesperson explained.
Musk co-founded Neuralink in 2016. The company is one of several projects under his leadership, alongside X, Tesla, SpaceX, and his AI startup xAI.
In addition to Blindsight, Neuralink is also working on an implant intended to enable paralyzed individuals to interact with digital devices through brain signals.
Earlier this year, Noland Arbaugh, a 30-year-old man from Arizona who was paralyzed from the neck down after a diving accident, became the first person to receive a Neuralink implant. Since the procedure, Arbaugh has been able to play video games, browse the internet, post on social media, and control a laptop cursor using only his mind.
In August, Musk announced that Neuralink had successfully implanted a brain chip in a second human patient.
While widespread use of these brain chips is still some time away, Musk has consistently expressed confidence in their safety. In December 2022, he stated that he would feel "comfortable" implanting one of the devices into his own children’s brains.