Neuralink says the Food and Drug Administration has granted “breakthrough device” designation to its experimental blindsight implant, which the company is developing with the aim of restoring vision to the visually impaired.
Manufacturers who apply for and receive FDA’s voluntary Breakthrough Device Program designation are given “the opportunity to engage with FDA experts through several different program options and efficiently address issues that arise during the premarket review phase.” FDA prioritizes breakthrough devices for review. Ultimately, breakthrough device designation can accelerate the development of technology. Last year, FDA granted this designation to 145 medical devices.
Blindsight is different from Telepathy, an implant that allows spinal cord injury patients to control computers with their thoughts, play video games or design 3-D objects. Neuralink owner and founder Elon Musk said in August that the company had implanted the chip in a second patient.
Musk claimed in March that Blindsight “is already working on monkeys, and while the resolution will be low at first, like early Nintendo graphics, it could eventually exceed normal human vision.” (Federal investigators have reportedly been looking into Neuralink’s animal testing, but Musk said in March that “no monkeys have been killed or seriously injured by our devices.”)
Neuralink’s Blindsight device can help restore vision to people who have lost both eyes and their optic nerves.
With an intact visual cortex, people who were born blind could see for the first time.
To set expectations correctly, vision… https://t.co/MYLHNcPrw6 pic.twitter.com/RAenDpd3fx
— Elon Musk (@elonmusk) September 17, 2024
Blindsight “allows vision to those who have lost both eyes and optic nerves,” Musk said following the FDA designation. “If the visual cortex is intact, it could enable vision for the first time in people who were born blind.” Musk added that while Blindsight’s resolution will be low at first, “it could eventually exceed natural vision and allow vision at infrared, ultraviolet and even radar wavelengths.”
These are big claims, and Neuralink is still a long way from being able to fully restore sight to those who have lost their sight, if it actually happens at all. Neuralink is not the first company or research team to work on a vision-restoring implant. Meanwhile, as TechCrunch points out, Blindsight and similar technologies can’t help people who were born blind because those people “have not developed the biological ability to see through their eyes.”
