FDA Authorizes Marketing of Noninvasive Brain-Computer Interface to Assist Stroke Rehabilitation

The Food and Drug Administration (FDA) has authorized marketing of a new noninvasive brain-computer device (IpsiHand System; Neurolutions, Santa Cruz, CA) indicated for adults who are having poststroke rehabilitation for upper extremity mobility and grasping with the hand. The device is intended to facilitate muscle re-education and maintain or increase range of motion.

Using noninvasive EEG rather than an implanted electrode or other invasive feature, the device wirelessly conveys EEG signal to a tablet for algorithm analysis of the intended muscle movement. A signal is, in turn, sent to a wireless hand brace that moves the hand for assisted movement. 

The FDA assessed the effectiveness and safety of the device through clinical data submitted by the manufacturer, including an unblinded study of 40 patients over a 12-week trial. The FDA reviewed the device through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type and granted breakthrough device designation.

“Thousands of stroke survivors require rehabilitation each year,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices, FDA Center for Devices and Radiological Health. “Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies.”