FDA's groundbreaking device program aims to provide patients with timely access to medical devices.
Neuralink has received the US Food and Drug Administration's “groundbreaking” tag for devices that restore communication among individuals with severe language disorders, Elon Musk's brain implant company said in an X post Thursday.
The device will support people affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis and other neurotic disorders, the company said.
Health Regulator's groundbreaking device program, according to its website, aims to provide patients and healthcare providers with timely access to medical devices by speeding up development, ratings and reviews.
The FDA and Neuralink did not immediately respond to Reuters' request for comment.
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