“Elon Musk says Neuralink’s Blindsight implant is ready from an engineering standpoint and is only waiting on regulators before it can help people who are completely blind, or who have never seen, regain vision.”
Breakthrough Device Designation speeds up a review. It does not mean the device works. Musk’s evidence that an implant makes people born blind see is a post on X. Blaming the regulators before they rule is a Musk tradition.