# FDA Grants Neuralink Breakthrough Device Designation for Blindsight Vision Restoration Device

> fda · REPORTED · 2025-06-02

The FDA granted Breakthrough Device Designation to Neuralink's Blindsight device in June 2025, aimed at restoring vision in blind individuals, accelerating its regulatory review pathway. This follows a May 2025 Breakthrough Device Designation for Neuralink's speech restoration technology.

About Neuralink: Neuralink develops implantable brain-computer interface devices, including its Telepathy product for enabling paralyzed patients to control digital devices with thought, and Blindsight for vision restoration, serving patients with severe neurological conditions.

- Company: Neuralink
- Sector: medical_device
- Primary source: https://neuralink.com/updates/

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.