Neuralink Blindsight receives FDA Breakthrough Device Designation for visually impaired patients
Blindsight is a technology meant to bring functional eyesight back to patients who have lost it.
As Neuralink continues its efforts to develop brain interface technology, one of its irons in the fire is Blindsight, which is a technology and procedure meant to provide eyesight back to those who have lost or never had eyesight through new medical implant technology. This particular sector of Neuralink has reached a milestone, being categorized by the FDA as a Breakthrough Device Designation.
Neuralink announced the milestone for its Blindsight technology via its social media this week. With the FDA’s designation, as dictated by its webpages on the Breakthrough Device Designation topic, the FDA will support Blindsight’s pathway from development and research to patient access. That will also include pre-market approval and 510(k) clearance that deems the product safe and efficient for medical use and procedures. Neuralink has already opened its patient registry list for its technologies to allow patients to sign up for clinical trials.
We have received Breakthrough Device Designation from the FDA for Blindsight.
— Neuralink (@neuralink) September 17, 2024
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
The Neuralink company has seen a bit of success in preparing its product for human procedures. Earlier this year, the company completed its first human procedure, implanting a quadriplegic human patient with its N1 Implant. That patient was then able to play Sid Meier’s Civilization 6 entirely through brain activity. Since then, Neuralink has continued to develop and improve its technology with the help of these experimental trials.
With Blindsight now receiving the FDA’s Breakthrough Device Designation, Neuralink looks set to push forward with technology to help those with vision disabilities as well. Stay tuned as we continue to follow this story for further updates.
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replyTJ Denzer posted a new article, Neuralink Blindsight receives FDA Breakthrough Device Designation for visually impaired patients
