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.