'Could restore sight': FDA grants 'breakthrough status' to Musk’s Neuralink 'Blindsight' implant. What it means

US Food and Drug Administration on Tuesday granted "breakthrough device" status to Elon Musk's Neuralink's experimental vision-restoring implant, Blindsight. This designation aims to speed up the development and review of innovative medical devices that address severe conditions.
Musk explained that the device could allow individuals who have lost both eyes and their optic nerve to regain sight.For those who have been blind from birth, provided their visual cortex remains intact, the device could offer vision for the first time. Musk described the initial vision quality as being akin to early video game graphics but suggested that future advancements could lead to vision that surpasses natural sight, including the ability to perceive infrared, ultraviolet, or radar wavelengths.
"To set expectations correctly, the vision will be at first be low resolution, like Atari graphics, but eventually it has the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths," Musk said in a post on X.

The breakthrough device designation from the FDA is intended to accelerate the development of devices that offer promising new treatments or diagnostic capabilities for life-threatening conditions. Neuralink, founded by Musk in 2016, is working on brain chip interfaces designed to be implanted in the skull. These chips could potentially restore vision, aid in movement, and facilitate communication for patients with disabilities.
Neuralink's Blindsight device has not yet begun human trials, and the company did not provide a timeline for when these trials might start. The FDA has not yet commented further on the development.
In addition to the vision-restoring implant, Neuralink is also testing another device aimed at helping paralyzed individuals control digital devices using only their thoughts. This ongoing study is expected to include three patients and span several years. Earlier this year, Neuralink successfully implanted the device in a patient who has since used it to play video games and design 3D objects.