Written and Reviewed by Team Pharmacally
Neuralink, founded by Elon Musk, the neurotechnology company has taken great steps in getting FDA-certified brain implants, mainly in aiding individuals with paralysis and vision impairment.
Advancements in Assisting Paralysis
In January 2024, Neuralink implanted its N1 brain computer interface (BCI) chip into quadriplegic patient Noland Arbaugh. The implant allowed Arbaugh to control a computer cursor with his thoughts, marking a significant milestone in BCI technology. However, the device encountered some problems, such as the detachment of some electrodes, which affected its performance. Neuralink addressed these issues by refining their algorithms and surgical techniques. Then, another patient received a better implant that showed excellent stability and function. This patient was able to play video games and design 3D objects with computer-aided design software by August 2024.
Initiatives in Vision Restoration
In September 2024, the “Blindsight” implant from Neuralink received a so-called “breakthrough device” designation by the FDA. The implant is designed to restore vision for people who have both lost their eyes and their optic nerve. Optimistically, this may even benefit people born blind. According to the FDA, breakthrough devices are medical devices that provide a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating condition. Although this acceptance speeds up the development process, it does not mean that the market will approve it right away. Neuralink has not yet set a date for human trials of the Blindsight implant.
Regulatory Milestones and Future Directions
In May 2023, Neuralink received approval from the FDA to start conducting human clinical trials. The early tests have involved individuals with serious spinal cord injuries in order to determine the safety and effectiveness of the implants. The owner of the corporation, Elon Musk, has stated that he would want to increase the size of those participating in the experiments and that, by the end of 2025; devices will be implanted in 20 to 30 other people. These developments highlight Neuralink’s dedication to enhancing BCI technology for the improvement of life quality for those with neurological impairments.
In summary, Neuralink FDA-approved brain implants are reportedly showing much promise in early human trials, especially in restoring motor functions for paralyzed individuals. In addition to the ongoing vision restoration, the BCI technology is only expected to revolutionize the field to deal with other various neurological challenges.
References:
1. Neuralink implanted second trial patient with brain chip, Musk says, Reuters, 5 Aug 2024
2. Neuralink’s first brain chip implant developed a problem — but there was a workaround, CNN Business, 09 May 2024
3. Neuralink’s Brain Chip: How It Works and What It Means, Capitol Technology University, 09 Feb 2024
4. Waisberg, Ethan; Ong, Joshua1; Lee, Andrew G.2, 3,4,5,6,7,8,9. The potential to restore vision with Neuralink’s “Blindsight” neural interface technology. The Pan-American Journal of Ophthalmology 6(3):84, May 2024. | DOI: 10.4103/pajo.pajo_36_24
5. Musk’s Neuralink gets FDA’s breakthrough device tag for ‘Blindsight’ implant, Reuters, 18 Sept 2024
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