Elon Musk Says Neuralink’s Blindsight Is Engineering-Ready, Pending Regulatory Approval

Elon Musk said Neuralink’s Blindsight device is ready from an engineering standpoint and is awaiting regulatory approval. According to Sina Finance, citing Musk’s posts on X, Neuralink’s two brain-computer interface products are Telepathy, designed for communication through thought, and Blindsight, intended to restore vision, including for people who have never had sight. The FDA granted Blindsight Breakthrough Device designation in September 2024 to expedite regulatory review, but the designation did not authorize commercial use. Both implants lack FDA commercial approval, and Neuralink has not demonstrated that Blindsight restores patients’ vision or that its clinical results establish general effectiveness.