Remedee Labs, a pioneer in non-pharmacological treatments for chronic pain, has achieved a major regulatory milestone by obtaining medical device status in Europe for its millimeter wave endorphin stimulator wristband. This device is now the first to be clinically validated and certified in Europe specifically for fibromyalgia, a chronic disorder that had previously lacked targeted treatments. The breakthrough offers new hope to millions suffering from fibromyalgia, who now have access to an innovative solution for symptom relief.
The approval was backed by the FIBREPIK clinical study, which demonstrated significant benefits for fibromyalgia patients using the Remedee wristband. Participants experienced improvements in pain reduction, fatigue, anxiety, depression, and sleep quality, showcasing the device's ability to enhance patients' quality of life. The study results were presented at the American College of Rheumatology's 2023 annual meeting, further validating the wristband’s effectiveness in clinical settings.
Additionally, Remedee Labs’ device received Breakthrough Device Designation from the U.S. FDA in 2022, further enhancing its global recognition. The company plans to launch the device for fibromyalgia patients in France by 2025, combining the technology with a comprehensive support program for chronic pain management.
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