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Elon Musk’s Neuralink Receives FDA Breakthrough Device Designation for ‘Blindsight’ Implant

Elon Musk's Neuralink Receives FDA Breakthrough Device Designation for 'Blindsight' Implant

Elon Musk’s brain-computer interface startup, Neuralink, has received FDA breakthrough device designation for its Blindsight implant, designed to restore vision in blind individuals.

The Blindsight device involves implanting a microelectrode array into the visual cortex of the brain, which activates neurons to generate a visual image for the user.

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Musk claims that this device could allow even those who have lost vision in both eyes and their optic nerve to see, provided their visual cortex remains intact. It may also enable individuals who have been blind since birth to see for the first time. He explained that while the initial visual experience will be low resolution—comparable to Atari graphics—it could eventually surpass natural vision, potentially allowing users to perceive infrared, ultraviolet, or even radar wavelengths, similar to the character Geordi La Forge from Star Trek.

Neuralink is actively seeking participants for its PRIME study, a clinical trial focused on its brain-computer interface (BCI) designed to enable individuals with quadriplegia to control digital devices using their thoughts.

Earlier this year, the company successfully implanted its device in a patient, who has since utilized the BCI for various activities, including playing video games and online chess. Neuralink received FDA approval last year to transition from animal testing to human trials for its BCI device.

According to the company’s website, Neuralink aims to develop a generalized input/output platform that can interface with all aspects of the human brain.

In a related field, Boston-based Neurable, a brain-computer interface technology firm, announced a partnership in March with Canadian precision health company Healthspan Digital. Together, they plan to offer neurotechnology solutions to health and longevity clinics worldwide to assist in evaluating individuals’ cognitive performance and brain health.

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