Elon Musk's Neuralink Achieves FDA Breakthrough Device Status for Blindsight Implant

Elon Musk's Neuralink brain chip receives FDA's 'breakthrough device'...

Elon Musk's brain chip firm Neuralink has received "breakthrough device" status for an implant aimed at helping blind patients regain their sight, the firm announced Wednesday. Dubbed "Blindsight," the experimental brain implant gained clearance from the US Food and Drug Administration to participate in the voluntary program. It is one of 58 devices to receive the designation so far this year, according to the FDA. Musk - who is known for making bold proclamations about his companies' products long before they hit the market - celebrated the FDA's decision by sharing a photo of "Star Trek: The Next Generation" actor LeVar Burton, whose character Geordi La Forge used a futuristic visor to see. "The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see," Musk wrote on X. "Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time." The FDA did not immediately return The Post's request for comment. The "breakthrough device" program is aimed at "speeding up development, assessment and review for premarket approval" for medical devices that treat life-threatening or permanent conditions - as long as they meet safety standards, according to the agency's website. "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, like Geordi La Forge," Musk added. Musk co-founded Neuralink in 2016. It is one of many projects for the tech titan, who also owns X and the artificial intelligence startup xAI while also serving as CEO of Tesla and SpaceX. Neuralink is also developing an implant that aims to allow paralyzed patients the ability to use digital devices with their brains. In January, Noland Arbaugh, a 30-year-old Arizona man who was paralyzed from the neck down after a diving accident, became the first human to receive a Neuralink implant.

Elon Musk's Neuralink gets FDA's 'breakthrough device' tag for this - Times of India

Elon Musk-owned brain-chip startup, Neuralink, has achieved a major milestone from the US Food and Drug Administration (FDA). The public health agency has granted the company's experimental vision implant the "breakthrough device" tag. This tag is awarded to medical devices that offer treatments or diagnoses for life-threatening conditions. The FDA aims to accelerate the development and review of such devices, and the breakthrough tag signifies the potential for significant benefits to patients. What the company said In a post shared on X, the startup wrote: "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. Apply to our Patient Registry and openings on our career page." In a separate post, Musk said: "The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see. Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time. To set expectations correctly, the vision will at first be low resolution, like Atari graphics, but eventually, it has the potential to be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge. Much appreciated @US_FDA!" However, Neuralink has yet to share details about when it expects the Blindsight device to move into human trials. Other health devices being tested by Neuralink Neuralink, founded by Elon Musk in 2016, is working on another technology that could restore vision and movement for specially-abled patients. The company's implant can be surgically placed within the skull to process and transmit neural signals which will enable communication with external devices like computers or phones. The company is also conducting research on another implant designed to help specially-abled patients control digital devices using only their thoughts. This technology holds potential for individuals with spinal cord injuries. A clinical trial is currently underway to evaluate the effectiveness of this implant. Three patients have already participated in the study, which is expected to last several years. Earlier this year, Neuralink successfully implanted the device in a second patient who has been using the implant to play video games and learn 3D design. This demonstrates the technology's potential to enhance the lives of those with special abilities. The TOI Tech Desk is a dedicated team of journalists committed to delivering the latest and most relevant news from the world of technology to readers of The Times of India. TOI Tech Desk's news coverage spans a wide spectrum across gadget launches, gadget reviews, trends, in-depth analysis, exclusive reports and breaking stories that impact technology and the digital universe. Be it how-tos or the latest happenings in AI, cybersecurity, personal gadgets, platforms like WhatsApp, Instagram, Facebook and more; TOI Tech Desk brings the news with accuracy and authenticity.