Neuralink’s Sight Implant Gets “Breakthrough Device” Tag from FDA

The United States Food and Drug Administration (FDA) gave Neuralink’s experimental implant to restore sight, Blindsight, the “breakthrough device” tag this Tuesday.

According to Reuters, this designation is provided to medical devices that can diagnose or treat severe medical conditions, and it’s intended to speed its development and review processes.

The update was shared on X by the neurotechnology company. “We have received Breakthrough Device Designation from the FDA for Blindsight,” states the post. “Join us in our quest to bring back sight to those who have lost it. Apply to our Patient Registry and openings on our career page.”

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. Apply to our Patient Registry and openings on our career page https://t.co/abBMTdv7Rh

— Neuralink (@neuralink) September 17, 2024

Elon Musk, co-founder of Neuralink, said on X that Blindsight is aimed to help those patients “who have lost both eyes and their optic nerve to see.” He explained that people who were born blind but still have a visual cortex could be able to see for the first time with the implant and mentioned that those who get the implant might see in low quality at first, but that within time their sight could be even better than natural vision and compared it to the fictional character from the show Star Trek, Geordi La Forge.

However, multiple news outlets have explained that Musk’s message is misleading and has also been considered “irresponsible” by the online news site Techcrunch. Journalist Devin Coldewey explained that the update does not imply that there is a cure for blindness, that it is still too premature to guarantee such results and Musk has publicly made big promises that might not be realistic.

Coldewey acknowledges that Neuralink has developed a powerful technology and that Blindsight can contribute to further medical advances.

While Musk has a reputation for making unfulfilled promises, Neuralink has made significant progress with its technology. The company recently installed another Link implant for the PRIME Study successfully on a second patient.