Elon Musk’s Neuralink receives FDA’s breakthrough designation for its ‘Blindsight’ implant.

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On Tuesday, Elon Musk’s brain-chip venture, Neuralink, announced that its experimental vision-restoring implant has been granted the “breakthrough device” designation by the U.S. Food and Drug Administration (FDA).

This designation is reserved for specific medical devices that offer treatment or diagnostic capabilities for life-threatening conditions, with the goal of accelerating their development and review processes.

According to Musk, the experimental device, referred to as Blindsight, has the potential to allow individuals who have lost both their eyesight and optic nerves to regain their ability to see, as he shared in a post on X.

Neuralink has not yet provided a response regarding the timeline for the Blindsight device’s transition to human trials. Similarly, the FDA has also not commented on the matter.

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Established in 2016 by Elon Musk along with a team of engineers, Neuralink is developing a brain chip interface that can be surgically placed within the skull. This technology aims to assist disabled individuals in regaining mobility and communication abilities, and potentially restore vision.

The device features a chip that captures and transmits neural signals, allowing them to be sent to various devices such as computers and smartphones.

In addition, Neuralink is conducting separate trials for an implant created to enable paralyzed individuals to operate digital devices solely through thought, a development that holds promise for people with spinal cord injuries.

This study is set to include three participants and will evaluate the device over several years, as noted in the clinical trials database managed by the U.S. government. Earlier this year, the company successfully implanted the device in its second participant, who has been using it to play video games and design 3D objects.