NElon Musk’s neurotechnology startup euralink announced Tuesday that its experimental vision-restoring implant has received “breakthrough device” designation from the U.S. Food and Drug Administration (FDA).
On Tuesday, September 17, Neuralink received the FDA’s “Breakthrough Device” designation for Blindsight, the startup’s device designed to restore sight to the blind. Elon Musk expressed his delight at obtaining this label in a note published on X.
Neuralink, which was founded in 2016 by Musk and a group of engineers, is building a brain chip interface that can be implanted in the skull, which it says could eventually help disabled patients move and communicate again, and also restore vision.
According to Musk, this device “will allow even those who have lost both eyes and their optic nerve to see. (…) It will even allow those who are blind from birth to see for the first time.” He also specifies that the vision will be low resolution at first, but that it has the potential to become better than human vision.
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Still some progress to be made
While the FDA designation is a step forward for Blindsight, it doesn’t mean the product is ready, but rather that the startup is now authorized to conduct more tests while being more closely monitored by the American agency.
The FDA explains on its website that this qualification of “breakthrough device” is intended for “certain medical devices and device-based combination products that allow more effective treatment or diagnosis of life-threatening or irreversibly disabling diseases or conditions.”
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It will allow Neuralink to expedite the development, evaluation and review of Blindsight for market entry. The FDA also hopes to “provide patients and health care providers with rapid access” to the medical device.
Earlier this year, Neuralink placed its first brain implant in a 29-year-old quadriplegic patient, who was later able to control a computer mouse with his mind.
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