Elon Musk’s Neuralink(brain-chip company), has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its experimental vision-restoring implant, Blindsight. The announcement was made on Tuesday, September 17. This new implant is designed to help people with full or partial blindness, including those whose optic nerves are no longer functional.
The Blindsight device is intended to restore vision for individuals who have lost their sight. It targets people with severe visual impairments, including those whose optic nerves no longer transmit signals to the brain.
Neuralink shared the news on its X page (formerly Twitter), stating:
“We have received Breakthrough Device Designation from the FDA for Blindsight. Join us in our quest to bring back sight to those who have lost it.”
The company also invited people to apply to their patient registry and job openings via their career page.
The FDA’s Breakthrough Device Designation is reserved for medical devices that address serious or life-threatening conditions. This designation helps speed up the development and approval process for the device, allowing it to reach patients more quickly.
Elon Musk also shared the news on his social media, explaining the potential of Blindsight to restore vision, even in severe cases. According to Musk, the device could allow those who have been blind since birth to see for the first time.
Musk highlighted the implant’s potential, writing:
“If the visual cortex is undamaged, Blindsight can enable even those who were born blind to experience vision. Initially, the resolution might be low, similar to early video game graphics, but over time, the technology could surpass natural vision and allow users to see infrared, ultraviolet, or even radar wavelengths.”
Musk drew a comparison to Geordi La Forge, a character from Star Trek who uses advanced technology to “see” in various spectrums beyond human sight.
Neuralink, which was co-founded by Elon Musk in 2016, aims to create advanced brain-computer interfaces (BCIs) to treat neurological conditions. The company’s technology involves a brain implant that reads neural signals and transmits them wirelessly to devices like computers or smartphones.
Beyond Blindsight, Neuralink is working on other projects, including an implant designed to help people with paralysis control digital devices using their thoughts. Currently, the company is conducting clinical trials involving three participants to test this technology’s effectiveness in helping individuals with spinal cord injuries.
In August 2024, Neuralink successfully implanted its brain-computer interface in a second patient. This individual can now control video games and create 3D designs using only their thoughts.
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