Elon Musk’s brain-chip startup Neuralink announced that its experimental implant designed to restore vision has been granted the US Food and Drug Administration's (FDA) "breakthrough device" designation.
The device, called "Blindsight," aims to help people who have lost their vision, including those who are completely blind and lack functioning optic nerves. Musk shared the news on his social media platform X, stressing the device’s potential to enable sight restoration even in severe cases of blindness.
The FDA's breakthrough designation is reserved for medical devices that address life-threatening conditions, with the goal of speeding up their development and regulatory review process. While Neuralink has yet to confirm when human trials for the Blindsight device will begin, this designation marks a significant step in advancing the technology toward clinical testing.
Founded in 2016 by Musk and a team of engineers, Neuralink focuses on developing brain-computer interfaces that could revolutionize treatments for neurological conditions. Its brain implant processes neural signals and transmits them to external devices like computers or smartphones. The company has also been working on an implant for paralysed individuals, designed to allow users to control digital devices with their thoughts.
Neuralink is currently conducting a trial involving three patients to test the device's ability to assist people with spinal cord injuries. The company recently implanted the device in a second patient, who is now using it to play video games and design 3D objects through mental commands.
