Neuralink achieves 40-word-per-minute milestone as FDA approves expanded trial enrollment

A patient sustained 40 words per minute over two months using neural signals alone, as regulators cleared the way for 15 more participants to join the trial.

The Food and Drug Administration issued written approval on Thursday expanding enrollment in Neuralink's PRIME study to fifteen additional participants, as the trial's first patient demonstrated a sustained typing rate of 40 words per minute using neural signals alone over a two-month evaluation period.

The FDA's written approval cited clean safety data and demonstrated device functionality as the basis for clearing the expanded enrollment. No incidents of device migration, infection, or serious adverse events had been reported across either of the two current participants.

The 40-words-per-minute result was recorded consistently by the first PRIME study participant over the two-month evaluation period using only neural activity, without physical keyboard input. Neuralink's chief executive described the result as a proof point, not a ceiling.

The enrollment expansion does not constitute full commercial authorization. It represents a broadening of the ongoing research trial, subject to continued regulatory oversight.

Neuralink said the expanded cohort was expected to include participants with a range of conditions affecting motor function, including ALS, spinal cord injury, and stroke.