Neuralink’s chip issue, where some threads “retracted” from its first human patient’s brain, has reportedly been known for years, according to Reuters. Five anonymous sources familiar with the company, citing non-disclosure agreements, revealed this longstanding problem.
Despite the issue, Neuralink hasn’t changed the chip’s design, considering the risk too low to address. Previous tests on animals indicated possible thread retraction, and the US Food and Drug Administration (FDA) was reportedly aware.
The FDA stated it “does not discuss or disclose conversations with any particular sponsor” but receives “regular progress reports” to assess “safety and data quality.” These reports should summarize all anticipated and unanticipated adverse effects, and the FDA will continue to “monitor the safety of those enrolled in the study for Neuralink’s implant device.”
Neuralink recently updated on its first human patient, mentioning that some N1 chip thread wires had disconnected unexpectedly. The company modified its recording algorithm to maintain data capture despite the disconnections, enhancing neural signal translation and user interface. However, more thread retractions may require removing the chip entirely.
Neuralink, co-founded by Elon Musk, aims to create a brain chip allowing people to control computers with their thoughts. The FDA authorized human trials last year, and Neuralink highlighted the successes of its first patient, Noland Arbaugh, a quadriplegic who can now play video games using only his mind.
US lawmakers, however, have questioned the FDA’s oversight, citing concerns over Neuralink’s animal testing, record-keeping, and medical instrument calibration. US Rep. Earl Blumenauer sent a letter to the FDA earlier this year citing “troubling evidence” and calling for further investigation before human trials began.
