FDA grants Breakthrough Device designation to Wavegate for StimuLux system

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Wavegate Corporation has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for its StimuLux optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation (SCS).

“We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux technology,” said Wavegate CEO Erich Wolf. “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 Wavegate’s Ellipse neuromodulation platform, which integrates multiple patented technologies that aim to systematically address unmet clinical needs within the neuromodulation industry.

As per a press release from Wavegate, StimuLux optical reflectometry is limited by US federal law to investigational use only.


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