Neuralink Receives FDA ‘Breakthrough Device’ Designation for ‘Blindsight’ Implant
Elon Musk’s brain chip startup Neuralink reported Tuesday that its experimental implant aimed at restoring vision has been granted “breakthrough device” status by the U.S. Food and Drug Administration.
The FDA’s breakthrough designation is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is intended to accelerate the development and review of devices currently in development.
The experimental device, known as Blindsight, “will allow even people who have lost both eyes and their optic nerve to see again,” Musk said in a post on X.
Neuralink did not immediately respond to a request for details on when it expects the Blindsight device to enter human trials. The FDA also did not immediately respond to a request for comment.
Neuralink, founded in 2016 by Musk and a group of engineers, is building a brain chip interface that can be implanted in the skull. The company says this interface could eventually help disabled patients regain movement and communication, as well as restore their vision.
Neuralink’s device contains a chip that processes and transmits neural signals so they can be passed on to devices such as a computer or phone.
The startup is also testing an implant that allows paralyzed patients to control digital devices by simply thinking about them, a prospect that could help people with spinal cord injuries.
According to data in the U.S. government’s clinical trials database, three patients are expected to be enrolled to evaluate the device. The study is expected to last several years.
Earlier this year, Neuralink successfully implanted the device in its second patient, who uses it to play video games and learn how to design 3D objects.
© Thomson Reuters 2024
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