Elon Musk's Neuralink receives FDA 'breakthrough device' certification for 'Blindsight,' an implant that can restore vision to people who have lost their optic nerve



Neuralink , the company co-founded by Elon Musk to develop brain-machine interfaces, has announced that its experimental implant, Blindsight, has received 'breakthrough device' certification from the U.S. Food and Drug Administration (FDA).

Musk's Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant | Reuters
https://www.reuters.com/business/healthcare-pharmaceuticals/musks-neuralink-receives-fdas-breakthrough-device-tag-brain-implant-2024-09-17/



The FDA's Breakthrough Device designation is given to certain medical devices that treat or diagnose life-threatening diseases and is intended to expedite the development and review of devices in the development stage.

Neuralink posted on its official Twitter account, 'We have received Breakthrough Device Designation from the FDA for Blindsight. Join us in our efforts to restore sight to those who have lost their sight. Patient registration and job openings are available on our careers page.'




Co-founder Musk posted, 'Neuralink's Blindsight could restore vision to people who have lost the optic nerves in both eyes. With an intact visual cortex, people born blind could be able to see for the first time. To set expectations right, vision will initially be low-resolution, akin to Atari graphics, but ultimately could be superior to natural vision, with the ability to see in infrared, ultraviolet and radar wavelengths like Geordi La Forge . Thanks so much, FDA!'




Reuters asked for details, including when Blindsight plans to move into human clinical trials, but Neuralink and the FDA did not immediately respond to requests for comment.

Neuralink was founded in 2016 by Musk and a group of engineers to develop a brain-machine interface that can be implanted inside the skull. The brain-machine interface developed by Neuralink could eventually enable disabled patients to move again, communicate, and even regain their sight. Neuralink's devices are characterized by chips that process and transmit neural signals that can be sent to devices such as computers and smartphones.

Separate from Blindsight, Neuralink is also testing an implant designed to let paralyzed patients control digital devices with just their thoughts, potentially helping those with spinal cord injuries. The test will enroll three patients to evaluate the device in a study expected to take several years, according to details in the US government's clinical trials database.

A quadriplegic patient who underwent Neuralink's brain implant surgery reported 100 days after the operation that he was able to play games such as Mario Kart just by thinking about them - GIGAZINE



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