PARIS , Sept. 16, 2024 /PRNewswire/ -- Remedee Labs, a French start-up that specializes in non-pharmacological treatments for chronic pain, is announcing today that it has obtained medical device status in Europe for its millimeter wave endorphin stimulator wristband . The Remedee Labs solution is now the first medical device clinically validated and certified in Europe to provide symptom relief for fibromyalgia, a disorder for which no specific treatment had previously been identified.
This achievement marks a major advance in care for the millions of patients suffering from fibromyalgia. "Obtaining European medical device status for the indication fibromyalgia is a major milestone for Remedee Labs, but above all for people living with fibromyalgia, who previously lacked access to any approved and dedicated treatments for their condition, " says Dr. David Crouzier (PhD), co-founder, CEO of Remedee Labs.
The solution's obtention of medical device status was supported by the FIBREPIK clinical study, the results of which were presented at the annual meeting of the American College of Rheumatology (ACR) in 2023. The study's results showed that using the RemedeeTM wristband for three 30-minute sessions per day produced a clear improvement in participants' quality of life, with a significant decrease in pain, generalized and physical fatigue, anxiety, and depression, as well as an improvement in sleep quality. Remedee Labs' solution for patients with fibromyalgia has also been rec.