FDA grants StimuLux system breakthrough device designation

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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. 

Breakthrough device designation aims to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.

Erich Wolf, chief executive officer of Wavegate Corporation, said: “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. 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 Corporation’s Ellipse neuromodulation platform which integrates multiple patented technologies that aim to systematically address unmet clinical needs within the neuromodulation industry.

StimuLux optical reflectometry is limited by federal law to investigational use only.


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