Musk's vision implant gets FDA breakthrough device tag - European Medical Journal

Musk’s vision implant gets FDA breakthrough device tag

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EMJ GOLD
Words by Jade Williams

Neuralink, Elon Musk’s brain-chip startup, has been given breakthrough device designation from the FDA for its experimental implant aimed at restoring vision.  

Breakthrough device designation is reserved for novel devices intended to treat or diagnose life-threatening or debilitating conditions, facilitating accelerated development, regulatory review and approval for such devices to help them reach patients more rapidly. 

The brand’s implant has the potential to restore vision, and “will enable even those who have lost both eyes and their optic nerve to see,” according to Musk’s post on X. However, details regarding the timeline for human trials of the device remain unclear. 

In parallel to its work on this vision device, Neuralink is developing another brain implant designed to enable paralysed patients to control digital devices purely through thought. This innovation could offer new therapeutic options for patients with spinal cord injuries or neurodegenerative diseases. 

The clinical trial for Neuralink’s paralysis therapeutic is still ongoing and is expected to span several years, however, the device has already been successfully implanted in two patients. 

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