CDSCO approves xStep device for treatment of paralysis in India

VIVATRONIX Tech and SpineX Inc. have announced that the Central Drugs Standard Control Organization (CDSCO) has approved xStep (powered by SpineX) for clinical and home use in India.

The xStep device delivers painless, noninvasive electrical stimulation to the spinal cord—without the need for surgery—to help restore motor function, mobility, and independence in individuals living with paralysis.

Formerly known as SCiP™ or SCONE™, the xStep technology has been recognised by the US Food and Drug Administration (FDA) as a Breakthrough Device for two distinct indications. It has demonstrated promising results in multiple global clinical trials, and SpineX continues to collaborate on investigator-initiated studies validating the safety, efficacy, and transformative potential of noninvasive spinal neuromodulation therapy.

With CDSCO approval, SpineX Inc. and VIVATRONIX Tech are poised to expand access to advanced neurorehabilitation technology in India and worldwide—marking a major step toward transforming the standard of care for individuals living with paralysis.