SpineX and VIVATRONIX Tech’s xStep Receives Approval from CDSCO 

Key Highlights: 

• SpineX and VIVATRONIX Tech announced that their noninvasive neuromodulation device, xStep, has received regulatory approval from the Central Drugs Standard Control Organization for both clinical and home use in India. 

• The xStep delivers painless electrical stimulation to the spinal cord without requiring surgery, helping restore motor function, mobility, and independence for individuals living with paralysis. The technology was previously known as SCiP/SCONE and has demonstrated promising outcomes in multiple international clinical studies. 

• The device has also received US FDA Breakthrough Device designation for two indications. With the CDSCO approval, the companies aim to expand access to advanced neurorehabilitation therapies in India while advancing global adoption of noninvasive spinal neuromodulation.  

Implications:  

xStep revolutionizes neurorehabilitation by bringing hospital-grade spinal stimulation into patients’ homes, exploding access for spinal cord injury and stroke survivors. 
Dual clinical/home approval hands physiatrists powerful outpatient therapy that slashes rehab center dependency while boosting long-term compliance. 
Noninvasive breakthrough accelerates paralysis care transformation, positioning India as global leader in accessible neuromodulation therapies. 

Source: Businesswire