www.fdanews.com/articles/174422-stimwave-wins-fda-clearance-for-spinal-cord-stimulation-system
Stimwave Wins FDA Clearance for Spinal Cord Stimulation System
December 9, 2015
Wireless medical devicemaker Stimwave Technologies has scored FDA clearance for its Stimwave Freedom-8A Spinal Cord Stimulation System for treatment of chronic back and leg pain.
The wireless, micro-technology neuromodulation system features eight-electrodes placed near surrounding nerves, to which the miniature device delivers small pulses of energy.
The system previously received FDA clearance for its four-electrode device last year.
Stimwave has also begun commercializing the device, and a nationwide launch is expected in January 2016. — Michael Cipriano