The US Food and Drug Administration (FDA) grants “breakthrough approval” to the Neuralink device.
On social media, Neuralink recently revealed that the FDA had awarded its medical device a “breakthrough tag” for helping individuals with severe speech impairments regain communication.
People with multiple sclerosis, cerebral palsy, spinal cord injury, stroke, amyotrophic lateral sclerosis (ALS), and other neurological disorders should benefit from Neuralink’s device.
Patients and healthcare professionals can use new medical devices sooner thanks to the US FDA’s “breakthrough devices program,” which expedites developing, assessing, and reviewing medical devices.
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