Neuvotion has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its first product, NeuStim.

NeuStim is a non-invasive, surgery-free wearable to electrically stimulate muscles dynamically to support hand movement recovery after stroke or spinal cord injury (SCI). It also lets clinicians scan and pinpoint stimulation targets via a touchscreen interface.

The company said by using the graphical interface on a lightweight mobile device, users can quickly set up and save stimulation profiles.

“At Neuvotion we are developing highly innovative technologies built on two decades of scientific research yielding effective and easy-to-use products,” said Chad Bouton, Neuvotion’s founder and CEO. “We are extremely excited about NeuStim, our first product, which we believe will be a game-changer in the neuromodulation, brain-computer interface, and neurorehabilitation markets.”

Neuvotion is a Stamford, Conn.-based early-stage company that’s developing artificial intelligence (AI)-driven neuromodulation tech and products for the neurorehabilitation, brain-computer interface (BCI), and physical therapy markets.

The company said it plans to release NeuStim in the coming year. Good Shepherd Rehabilitation, a not-for-profit rehab organization with over 70 locations in Pennsylvania and New Jersey, also commented on the device’s FDA nod. The organization is a test site for the newest rehabilitation technologies.

“We have been very impressed with Professor Bouton’s groundbreaking foundational research and Neuvotion’s highly innovative approach,” said Michael Spigel, PT, MHA, president and CEO of Good Shepherd Rehabilitation. “We look forward to continuing as a clinical research partner with Neuvotion. We feel that NeuStim is truly revolutionary and will help produce improved outcomes in stroke and spinal cord injury rehabilitation.”