FDA Gives De Novo Approval for Stroke Rehabilitation Device
The FDA has granted de novo approval for Neurolutions’ IpsiHand Upper Extremity Rehabilitation System, a brain-computer-interface device that helps rehabilitate upper extremity and hand, wrist and arm muscles in stroke patients.
The system uses a robotic device worn on the hand that is controlled by brain waves from the side of the brain not affected by stroke to control the robotic device on the hand that has been weakened by stroke.
The device demonstrated motor function improvement in all 40 patients enrolled in a clinical study, with only minor adverse events like fatigue, discomfort and temporary skin redness.
The agency said the device should not be used by patients with severe spasticity or rigid contractures in the wrist and/or fingers that would prevent the electronic hand brace from being properly fit or positioned for use.