News & Press
Neuralink files for FDA De Novo clearance for N1 BCI as assistive communication device
STAT News4/26/2026·04/26/26🌐 USA
Summary
Neuralink has filed a De Novo request with FDA seeking marketing clearance for the N1 implant as an assistive communication device for patients with ALS, spinal cord injury, and brainstem stroke. The filing is supported by data from the first 3 PRIME trial patients demonstrating safety and communication performance exceeding 40 words per minute.
Why it matters
A De Novo FDA filing marks Neuralink's formal transition from research to regulatory commercialization. Clearance would make the N1 the first FDA-cleared cortical BCI for communication, opening the door to insurance coverage and hospital deployment.
#ALS#BCI#FDA#Neural Interfaces
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