FDA accepts Neuralink's fix for thread retraction, clearing a second implant

Neuralink/N1 implant (Telepathy)

The FDA cleared Neuralink to implant a second patient after approving the company's proposed design fix for thread retraction observed in its first patient. The solution increases implant depth from approximately 5mm to 8mm into the brain, addressing the issue where about 85% of the implant's hair-thin electrode threads came loose. Neuralink planned the second surgery for June 2024 and targeted 10 implants by year-end.

• First patient (Noland Arbaugh): ~85% of threads retracted weeks post-implant, reducing effective electrodes; software fixes restored performance beyond initial levels.
• Design change: threads inserted to 8mm depth instead of 5mm to reduce retraction risk; FDA approved revised protocol for second and subsequent patients.
• Timeline: second implant planned June 2024; target of 10 patients by end of 2024; expanded applications in Canada planned; fewer than 100 qualified from 1,000+ applicants.