Dive Brief: 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.