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FDA on Friday authorized Neurolutions device to help stroke patients regain movement in the arm, wrist and hand through use of a brain-computer interface to re-educate the muscles.
The noninvasive IpsiHand system translates neural activity on the ipsilateral, or uninjured, side of the brain into data that directs arm and hand function on the patient s impaired side. Brain waves are recorded via EEG electrodes placed on the patient s head and analyzed on a tablet, then a signal is sent to a wireless robotic brace that moves the person s hand.
FDA granted De Novo classification to the breakthrough-designated device based on data from Neurolutions unblinded study of 40 patients, all of whom showed improved motor function over 12 weeks.