Brain implants: What’s standing in the way of pivotal trials, FDA approval

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Source: STAT News

Original: https://www.statnews.com/2026/02/26/brain-computer-interface-fda-regulatory-hurd...

Published: Thu, 26 Feb 2026 09:30:00 +0000

Thirty years ago, scientists showed that brain implants allowed rhesus monkeys to move robotic limbs using only their minds.[1] Neuralink won FDA approval for first-in-human clinical testing in May, despite previous approval difficulties.[1][3][6] The testing involves the robotic implantation of 64 thin threads, thinner than a human hair, into the part of the brain that controls movement intentions.[1][3] These threads record brain signals that are wirelessly transmitted to an application for controlling a cursor or typing with thoughts.[1][3] The target group is patients with quadriplegic from trauma or amyotrophic lateral sclerosis (ALS).[1] The first patient, Noland Arbaugh, lost his mobility after a car accident, and Neuralink plans to implant the devices in ten people this year, with over 1,000 quadriplegics signing up.[4] The company is preparing to apply for permits in Canada and Britain, and competitors such as Synchron have already carried out similar implants.[3][4]