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Wednesday, 30 April, 2025
HomeNews UpdateMusk’s vision implant gets FDA’s breakthrough device tag

Musk’s vision implant gets FDA’s breakthrough device tag

Elon Musk’s brain-chip start-up Neuralink announced last week that its experimental implant aimed at restoring vision has received the US Food and Drug Administration’s “breakthrough device” designation, which is given only to certain medical devices that provide treatment or diagnosis of life-threatening conditions.

Reuters reports that it is aimed at escalating development and review of devices currently being developed.

Musk’s experimental ‘Blindsight’ “will enable even those who have lost both eyes and their optic nerve to see”, he said.

Neuralink has not said when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for comment.

Founded in 2016 by Musk and a group of engineers, Neuralink is building a brain chip interface that can be implanted within the skull, which it says could eventually help disabled patients to move and communicate again, and also restore vision.

The company is separately testing an implant designed to give paralysed patients the ability to use digital devices by thinking alone, a prospect that could help people with spinal cord injuries.

This trial is expected to enrol three patients to evaluate its device in a study anticipated to take several years to complete, according to details on the government’s clinical trials database.

 

Reuters article – Musk’s Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant (Open access)

 

See more from MedicalBrief archives:

 

US lawmaker probes FDA inspection of Musk’s Neuralink

 

Neuralink’s first human patient controls computer mouse via thought

 

FDA green-lights Musk’s brain implant for human study

 

 

 

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