Neuralink Secures FDA Breakthrough Device Designation for Link Brain-Computer Interface Amid IPO Preparations

Neuralink, Elon Musk’s brain-computer interface company, has achieved a major breakthrough. Reportedly, Neuralink’s brain-computer interface device, Link, recently received “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA). This designation demonstrates the medical regulatory authorities’ positive recognition of the device’s clinical application prospects, meaning it will be expedited through the medical device research and development, evaluation, and review processes.

Neuralink’s brain-computer interface (BCI) device is designed to help patients who have lost the ability to speak due to neurological disorders such as amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, and multiple sclerosis regain their communication capabilities. In Neuralink’s latest video, Bradford Smith, the third ALS patient to receive a BCI implant, successfully regained his ability to communicate with the aid of the Link device.

Neuralink implanted its first brain-computer interface device into a patient in January 2024. The subject gained widespread attention online for playing chess and posting on social media using only their thoughts. However, the device encountered some issues: partial connections between the implant and the patient’s brain became loose, and functionality declined as some electrode wires retracted. In August 2024, Neuralink completed the implantation procedure for a second patient with spinal cord injury. One month after surgery, this patient began playing video games and independently using 3D design software.

Currently, Neuralink is continuously expanding its global patient recruitment efforts.

In addition to restoring language function, Neuralink is also exploring applications such as visual reconstruction. Its visual restoration device, Blindsight, received FDA Breakthrough Device designation in 2024. Elon Musk has stated that this technology aims to help individuals with bilateral blindness and optic nerve damage “regain their sight.”

According to insiders, Neuralink is preparing for a new round of funding amounting to $500 million, with a pre-money valuation of approximately $8.5 billion and a post-money valuation expected to reach $9 billion.