Neuralink Blindsight's new FDA tag explained

09/18/2024 08:46 AM

Neuralink’s Blindsight implant recently received a “breakthrough device” designation from the US Food and Drug Administration (FDA). 

According to Elon Musk, Neuralink’s Blindsight device “will enable even those who have lost both eyes and their optic nerve to see.” Essentially, Blindsight is expected to help people regain their sight. 

Blindsight’s new designation from the FDA brings it one step closer to consumers. However, Neuralink still has many obstacles to overcome before Blindsight is available to the public. 

Blindsight’s current designation means the FDA considers it to be a medical device that promotes health equity. According to the FDA’s Breakthrough Device Program, technology that receives the designation is regarded as a device that may address inequities in new or existing medical instruments. 

The FDA’s Breakthrough Device Program is voluntary. Devices or device-led combination products may be designated under the program if they provide “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” 

Now that Neuralink’s Blindsight implant has received a breakthrough device designation, the company may receive help or request advice from FDA experts. FDA aid could help Neuralink develop Blindsight quicker and launch it faster on the market. 

In the meantime, Neuralink still has to launch its first brain implant device. The company’s human trials are progressing. Neuralink recently provided an update on its second patient to receive the brain implant.

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