FDA https://www.fda.gov has granted marketing authorization to Neurolutions, Inc., https://www.neurolutions.com for a new device for patients 18 and older undergoing stroke rehabilitation in order to overcome disabilities resulting from stroke damage.
The device will be used to facilitate muscle re-education and to maintain or increase range of motion. The device called the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) assists in rehabilitating stroke patients with upper extremity or hand, wrist, and arm disability.
The system uses non-invasive EEG electrodes instead of using an implanted electrode or other invasive features to record brain activity. The EEG data is wirelessly conveyed to a tablet for analysis of the intended muscle movement (intended motor function) and a signal is sent to a wireless electronic hand brace which in turn, moves the patient’s hand.
FDA assessed the safety and effectiveness of the device through clinical data submitted by Neurolutions with 40 patients over a 12 week trial. All participants demonstrated motor function improvement with the device over the trial.
The IpsiHand System device was granted Breakthrough Device designation which is a process designed to expedite the development and review of devices that may provide for more effective treatment if the diagnosis is life threatening or is considered an irreversible debilitating disease or condition.