Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'
Briefly

The FDA's designation of the Blindsight implant as a breakthrough device indicates significant potential in restoring vision for blind individuals, facilitating faster development and review.
Elon Musk emphasized that Blindsight, while initially providing low-resolution imagery akin to early video games, holds promise for ultimately exceeding normal human vision, even for those blind from birth.
The Blindsight device is designed to enable vision restoration for individuals who have lost both their eyes and optic nerve, assuming their visual cortex remains intact.
Receiving the breakthrough device designation allows Neuralink to collaborate closely with FDA experts, expediting the review process and increasing the chances of successful clinical deployment.
Read at Engadget
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