Wavegate’s StimuLux Earns Breakthrough Status

Wavegate Corporation has earned Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its StimuLux optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation.
 
“We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux technology,” Erich Wolf, MD, Ph.D., CEO told the press. “This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain. We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art.”
 
StimuLux is a component of the company’s Ellipse neuromodulation platform, multiple technologies that aim to address unmet neuromodulation clinical needs.