FDA “Breakthrough Device” designationNeuralink’s Blindsight—the brain implant meant to bypass damaged optic nerves and stimulate the visual cortex—received this status in September 2024. That’s significant, as it speeds up FDA review and early-stage testing .

FDA “Breakthrough Device” designation

Neuralink’s Blindsight—the brain implant meant to bypass damaged optic nerves and stimulate the visual cortex—received this status in September 2024. That’s significant, as it speeds up FDA review and early-stage testing  .

Elon Musk’s claim on timeline

Musk stated visions implants could be performed “in the next six to 12 months,” meaning by mid‑2025 to late‑2025  .

Scope of early testing

Initial trials will focus on individuals who are totally blind—possibly even those without an optic nerve and those blind from birth, provided their visual cortex remains intact  .

Expectations vs. reality

Musk cautioned that early vision would be “low resolution, like Atari graphics.” Researchers describe it as more of an augmentation or aid—providing rudimentary shapes, high-contrast outlines, or motion cues—not normal vision  .

Expert caution

IEEE Spectrum experts warn the tech may “disappoint” relative to Musk’s ambitious wording. It could be life-changing as an assistive tool, but natural or superhuman vision remains far off  .

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✅ Bottom line

Musk’s timeline (“by next year”) is grounded in the FDA’s breakthrough designation and the company’s expressed schedule.

Early vision will likely be extremely crude—think pixel-like perceptions or radar-like blips—rather than full sight.

Full clinical results and commercial approval are still years away, with much depending on forthcoming human trials.