Medical Technology and Regulation

Elon Musk said on X that his company Neuralink plans to begin 'high‑volume' production of its brain‑computer interface implants and move to an almost fully automated surgical procedure in 2026, marking a major scale‑up from its current small human trial. The fully implantable, 1.75‑inch‑thick device uses electrodes to read neural signals and translate them into digital commands, and the company says 12 people with severe paralysis worldwide have received the implant so far, including an Arizona man with ALS who now types using only his thoughts. Neuralink’s human trials began in 2024 after the FDA initially rejected its 2022 application over safety concerns, and the firm now claims future procedures will thread device leads through the dura without removing it.