Neuralink's speech restoration device gets FDA's 'breakthrough' tag

[highplainsdem]

Source: Reuters

Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for individuals with severe speech impairment, Elon Musk's brain implant company said on Thursday in a post on X.

The device would help those affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions, the company said.

The health regulator's breakthrough devices program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review, according to its website.

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Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/neuralinks-speech-restoration-device-gets-fdas-breakthrough-tag-2025-05-01/

[JoseBalow]

1. Credibility double-whammy

I'm supposed to trust Musk and a drumpf-led agency?

[Phoenix61]

2. Yet another grift by eloon. nt

[Balatro]

3. Trust nothing from this government.

nothing but plutocratic pestilence reigns.

[groundloop]

4. Was this approved by real doctors and scientists, or was it Krasnov appointees?

[Griefbird]

5. Stalking horse

Brain implant is the first stage of government mind control,