Tech billionaire Elon Musk’s company, Neuralink, has announced that its experimental Blindsight implant has received “breakthrough device” designation from the Food and Drug Administration (FDA).
According to Musk, the implant may enable individuals who have lost both eyes and even their optic nerve to regain some form of sight. He emphasized that the implant could potentially give those who have been blind since birth the ability to see for the first time, provided they have an intact visual cortex.
Blindsight is a Breakthrough
Manufacturers granted the breakthrough device designation are given “an opportunity to interact with FDA experts” to expedite the development and approval process, helping address regulatory issues early in the review phase.
This designation is reserved for medical devices with the potential to provide groundbreaking benefits, such as restoring vision for those who have lost it due to injury or degenerative conditions.
The FDA also prioritizes these devices for premarket evaluation. In 2023 alone, 145 medical devices received this designation, underscoring its significance in fast-tracking critical advancements in medical technology.
What Blindsight Could Mean for Vision Loss
Neuralink’s Blindsight device holds the promise of vision restoration for those who are entirely blind.
