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FDA approved first brain-computer interface stroke recovery device


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Neurolutions won FDA de novo authorization to introduce its IpsiHand stroke rehab system in the United States.

This is the first approval of a brain-computer interface technology for the rehabilitation of stroke patients.

Indicated for use in patients 18 and older undergoing stroke rehabilitation.

It promises a faster and complete recovery of hand function.

Takes advantage of the uninjured side of the brain to trigger a robotic exoskeleton placed over the affected arm.

Patient wears a brain-wave detecting EEG headset that interprets and sends signals to the exoskeleton.

“Neurons that fire together wire together,” - Neurolutions.

As the patient desires to move the hand, it actually does.

Performed repeatedly during multiple sessions at the clinic or independently at home.

Improve therapy outcomes, including muscle re-education and increased range of motion, long after (≥ 6 months) stroke diagnosis.

Adverse events reported included minor fatigue, discomfort, and temporary skin redness.

Neurolutions' robot exoskeleton improves recovery from disability in stroke patients

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Medical company developing brain-computer interface devices