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✅ Trusted source Elon Musk Noticia

Musk Says Blindsight Is Ready; Regulatory Approval Pending

📍 TeslaNorth

Elon Musk said in an X post dated October 29 that Blindsight, Neuralink's implant, is ready from an engineering standpoint and is only waiting on regulatory approval. According to Musk, it will allow people who are completely blind or have never seen to see. On September 17, 2024, Neuralink said the FDA had granted the program Breakthrough Device Designation for people with vision impairment, a step meant to speed review. Musk presents Blindsight as Neuralink's second product; the first, Telepathy, according to him will enable high-speed communication by thinking alone.…

🔎 Why it matters: Blindsight, Neuralink's second product, has held FDA Breakthrough Device Designation since September 2024 and, according to Musk, only awaits regulatory approval.
📈 Upside: The Breakthrough Device Designation aims to speed review of devices for serious conditions, per the article.
📉 Risk: The engineering-readiness claim comes from a Musk X post; the article cites no Blindsight trial data supporting it.
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