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Neuralink, Elon Musk’s brain-chip startup, has announced that its experimental brain implant, Blindsight, designed to restore vision, has received the U.S. Food and Drug Administration’s (FDA) “breakthrough device” designation. This designation, reserved for medical devices that address life-threatening or debilitating conditions, could accelerate the development and regulatory review process for Neuralink’s technology.
The device aims to provide vision even to those who have lost their eyes and optic nerves. In a post on X, Musk shared his optimism about Blindsight’s potential to “enable even those who have lost both eyes and their optic nerve to see.”
However, neither Neuralink nor the FDA has provided further details regarding the timeline for human trials, reports Reuters.
The Blindsight device is designed to process neural signals from the brain and transmit them to external devices such as computers or smartphones, potentially bypassing damaged or missing sensory organs.
While the breakthrough designation represents a major step forward, Blindsight is not the only technology Neuralink is pursuing. The startup is also testing a separate brain implant that would empower paralysed patients to interact with digital devices using only their thoughts.
This technology has already shown early success, with one patient reportedly playing video games and learning 3D design using the implant.
However, all was not well with the trials. In May 2024, reports emerged that Neuralink knew about the wire retraction issue from extensive animal testing, yet the management continued with the human trials.
In March 2024, Neuralink successfully conducted the first implant on Noland Arbaugh, a 29-year-old man paralysed from shoulder down. In May, reports came that the FDA approved Neuralink for the second implant. The company also proposed to embed some of the ultrathin wires deeper into the brain to address the retraction issue.
In July, the company began preparing for the tests and in August, the second patient received the implants. Later, Neuralink confirmed that there was no thread retraction issue with the second implant participant.
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