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Elon Musk’s Neuralink Declared Breakthrough Device By FDA

September 18, 2024
x min read

Neuralink continues to be on the leading edge of innovation for neuroscience. And now they are getting ready to begin trying to clinically validate a new technology for individuals who are blind.

What’s happening:

  • Elon Musk’s brain computer interface company Neuralink has been awarded a Breakthrough Device designation by the United States Food and Drug Administration for their Blindsight medical device

The big idea:

  • Blindsight is a new medical device that is aiming to restore sight in individuals who are blind or have significantly impaired vision
  • The medical device does this by implanting a micro electrode directly into the visual cortex of the brain and then activating neurons based on the inputs of a external camera which then produce visual images

Why it matters:

  • Neuralink’s new Breakthrough Device designation from the Food and Drug Administration will accelerate the clinical review process and regulatory assessment in an effort to expedite its availability to patients

Going deeper:

  • Neuralink previously successfully completed the world’s first computer chip implant into a human brain, which marked an enormous leap forward for their technology and for neuroscience as a whole
  • While many scientific researchers have explored medical devices that can restore vision, ultimately none have been successful in making meaningful improvements in vision for individuals who are blind which represents an enormous unmet medical need globally

The fine print:

  • It is currently unclear when human trials will officially begin for Neuralink’s Blindsight device and it is currently yet to be clinically validated by a large group of patients

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