The US Food and Drug Administration has granted Elon Musk’s Neuralink a “breakthrough device” designation for its experimental implant, Blindsight.
The device aims to restore vision for people with complete or partial blindness, including those with non-functional optic nerves.
Reacting to the development, Neuralink expressed excitement on its X page, stating: “We have received Breakthrough Device Designation from the FDA for Blindsight. Join us in our quest to bring back sight to those who have lost it.”
What it means
The FDA reserves this designation for medical devices targeting life-threatening conditions. With the nature of blindness, and what the Elon Musk device seeks to introduce, a “breakthrough device” designation from FDA will help it fast-track the development.
Explaining the intricacies, Elon Musk on his X page shared the potential impact of the breakthrough, noting that the device has the capacity to restore vision for the blind people.
“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see… the vision will at first be low resolution, like Atari graphics, but eventually… better than natural vision,” he said.
About Neuralink
Since its founding in 2016, Neuralink has been pushing boundaries in brain-computer interface technology, targeting neurological disorders.
The company is also working on an implant to enable paralyzed individuals to control digital devices with their minds.
What you should know
A clinical trial is currently underway with three participants, and a recent report has confirmed that one patient successfully controlled video games and created 3D designs “using only thoughts.”
Neuralink, as a company, continues to make waves in medical innovation, offering hope for those with vision and mobility impairments.
Its rejection by the USA
Media sources familiar with the development stated that the U.S. regulators had earlier rejected Elon Musk’s bid to test brain chips in humans, citing safety risks.
The agency during the approval attempt of the brain implant company outlined dozens of issues the company must address before human testing.
Meanwhile, Synchron, another brain-computer interface company, recently received FDA approval for its Stentrode device, which allows individuals with paralysis to control digital devices through thought.
