Wavegate announced today that it received FDA breakthrough device designation for its StimuLux optical reflectometry system.
Lake Charles, Louisiana-based Wavegate designed the StimuLux system for the closed-loop adaptive modulation of spinal cord stimulation. Breakthrough designation will expedite the development and regulatory review processes for the platform.
According to a news release, StimuLux makes up part of Wavegate’s Ellipse neuromodulation platform that integrates multiple patented technologies to address unmet clinical needs within the neuromodulation industry.
“We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux technology. This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain,” Wavegate CEO Dr. Erich Wolf said in the release. “We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art.”
