The Food and Drug Administration (FDA) has granted Elon Musk’s Neuralink approval to implant its experimental brain chip in a second patient, following challenges in their first trial. The Wall Street Journal reports that this approval includes a modified procedure aimed at addressing previous issues.
Neuralink’s brain-computer interface (BCI) technology aims to help individuals with full-body paralysis control external devices using their thoughts. This new approval comes after Neuralink encountered complications in its initial clinical trial. Some electrode-containing threads, designed to record neural activity, retracted from the brain of the first patient, 29-year-old quadriplegic Noland Arbaugh, who received the implant in February. Despite these setbacks, Arbaugh has used the device to play hands-free chess and video games like Mario Kart.
Both Neuralink and the FDA were aware from animal testing that these threads, thinner than a human hair, could retract. However, the risk was not considered significant enough to redesign the device. Neuralink did not respond to requests for comment, and the FDA declined to discuss the issue.
To address the problem, Neuralink will now embed the implant’s threads deeper into the brain, increasing the depth from three to five millimeters to eight millimeters within the patient’s motor cortex. This adjustment aims to improve the stability and functionality of the device.
The modified procedure follows Arbaugh’s experience, where only about 15% of the implanted threads remained in place. Neuralink adjusted the algorithm in Arbaugh’s implant to enhance its sensitivity to brain signals, partially restoring its capabilities.
Neuralink is currently seeking applications for another patient with quadriplegia to test the device’s potential for controlling phones and computers. This step forward is significant for the development of brain-computer interface devices, which hold promise for treating neurological disorders.
Meanwhile, Neuralink’s competitor, Synchron, is preparing for a large-scale clinical trial with the goal of seeking commercial approval. Additionally, Mass General Brigham has launched a collaborative effort with the FDA and other stakeholders to accelerate the development of implanted devices.
