Wrist-Worn Neurostimulation Device for Hand Movement Rehabilitation after Stroke or Spinal Injury Receives FDA Clearance

The Food and Drug Administration (FDA) has granted 510(K) clearance to NeuStim (Neuvotion, Stamford, CT), a noninvasive, surgery-free wearable neurostimulation device used to aid in hand movement recovery in patients who have experienced a stroke or spinal cord injury (SCI). The device can scan muscles to identify targets for high-precision electrical stimulation to enable neurorehabilitation.

The NeuStim device is worn on the wrist and provides dynamic stimulation capabilities designed to restore movement and sensation in the hands of individuals living with stroke or SCI. NeuStim is operated using a touch-screen interface on a lightweight mobile device, enabling clinicians to setup and save stimulation profiles for each patient. According to a statement from Neuvotion, the company expects to launch the device in the United States in 2025. The device was developed through a clinical research partnership with Good Shepard Rehabilitation (Allentown, PA), a not-for-profit organization that provides rehabilitation to patients with injuries, complex illnesses, and chronic conditions, including cardiovascular, neurologic, and developmental disorders.

"We look forward to continuing as a clinical research partner with Neuvotion,” said Michael Spigel, PT, MHA, President and CEO of Good Shepard Rehabilitation. “We feel that NeuStim is truly revolutionary and will help produce improved outcomes in stroke and spinal cord injury rehabilitation.”