www.fdanews.com/articles/206235-wavegates-spinal-cord-stimulator-stimulux-designated-a-breakthrough-device
Wavegate’s Spinal Cord Stimulator StimuLux Designated a Breakthrough Device
January 20, 2022
Wavegate’s StimuLux optical reflectometry system for spinal cord stimulation has been designated a breakthrough device by the FDA.
The device, which is designed to ease chronic pain, is a component of the Lake Charles, La.-based company’s Ellipse neuromodulation platform, which is designed to address unmet clinical needs in neuromodulation.
The FDA expedites regulatory reviews of breakthrough devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.