Neuralink, the Elon Musk-owned brain-computer interface company, has received “breakthrough device” clearance from the FDA. But this does not mean the outfit has developed a cure for blindness, whatever Musk might say. The breakthrough devices program at the FDA is a voluntary program that developers can apply to that, if granted, “offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase.
” The designation also lines them up for priority FDA review. In 2023, more than 30 medical devices were given this same breakthrough designation, and almost 1,000 have been authorized. Neuralink’s Blindsight is the latest, as the company announced Tuesday on X .
Blindsight is a new iteration of a technology that has been used for decades to experimentally restore very limited vision to certain blind people. A microelectrode array is embedded in the visual cortex and stimulates the neurons located there in patterns derived from a camera. In a way, it really is that simple to produce visual phenomena in people who may never have seen before.
Musk lost no time in asserting that Blindsight will “enable even those who have lost both eyes and their optic nerve to see. ..
. [I]t will even enable those who have been blind from birth to see for the first time.” But it is at best extremely premature to say that such a device could enable blind people to see.
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