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Home » FDA Designates Remedee Labs’ Fibromyalgia Treatment a Breakthrough Device
FDA Designates Remedee Labs’ Fibromyalgia Treatment a Breakthrough Device
The FDA has granted its Breakthrough Device designation to Remedee Labs for its endorphin stimulation device for the management of fibromyalgia.
The Paris, France-based startup describes the Remedee Well device as a new nonpharmaceutical approach to pain treatment, offering relief from major symptoms including pain, sleep disorders, fatigue and stiffness.
Early results from a clinical study showed a significant improvement in patients’ quality of life and an improvement in their sleep quality, the company said.
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