CDSCO Approves xStep Device for Non-Invasive Paralysis Treatment in India

VIVATRONIX Tech and SpineX have secured approval from India’s Central Drugs Standard Control Organisation (CDSCO) for the xStep device, offering a non-invasive solution to restore motor function in individuals with paralysis. The device delivers painless electrical stimulation to the spinal cord and is approved for both clinical and home use, providing an alternative to surgical interventions.

Previously known as SciP or SCONE, the technology has received the US FDA’s breakthrough device designation for two indications. Multiple global clinical trials have demonstrated promising outcomes, and SpineX continues to study the efficacy and safety of non-invasive spinal neuromodulation for neurological disorders, including paralysis and cerebral palsy.

Based in the US, SpineX develops spinal cord stimulation technologies, while VIVATRONIX Tech focuses on delivering advanced neurorehabilitation solutions in India and beyond. With CDSCO approval, patients now have access to a proven, non-invasive therapy, expanding opportunities for recovery and improved quality of life.

14-10-2025