Neuromodulation technologies developer Neuvotion has secured the US Food and Drug Administration (FDA) 510(k) clearance for the NeuStim device to support stroke and injury recovery.
NeuStim, Neuvotion’s first product, is a non-invasive, surgery-free wearable designed to stimulate muscles with high-precision electrically.
It aids hand movement recovery after stroke or spinal cord injury. Clinicians can use the built-in touch-screen interface to scan and pinpoint stimulation targets.
Stimulation profiles are easy to set up and save for each user via a graphical user interface on a mobile device.
US-based Neuvotion plans to launch NeuStim next year.
Neuvotion founder and CEO Chad Bouton said: “At Neuvotion we are developing highly innovative technologies built on two decades of scientific research yielding effective and easy-to-use products.
“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 an early-stage medical device company focused on restoring movement and sensation for patients with stroke, spinal cord injury, and other neurological conditions.
The company develops advanced technologies that combine neurostimulation and artificial intelligence (AI) for use in the neurorehabilitation, brain-computer interface (BCI), and physical therapy markets.
Their solutions aim to make physical and occupational therapy more effective and efficient.
In April 2023, Neuvotion secured an additional $1.25m in funding, raising total funding to over $2.75m. The round included investments from Northwell Holdings, Topspin Fund, and Long Island Angel Network.
The funding was intended to support the company in expanding its team, completing clinical studies, and obtaining FDA clearance for its first product.
Last December, the neuromodulation technologies developer expanded its partnership with Intelligent Product Solutions (IPS), a New York-based engineering firm.
Under the deal, Forward Industries, the parent company of IPS, made an undisclosed investment in Neuvotion to accelerate the market launch of NeuStim.
