Remedee Labs’ Solution becomes the first CE marked medical device (class IIa) approved for the treatment of fibromyalgia in Europe Read the press release.
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Remedee Labs’ Solution becomes the first CE marked medical device (class IIa) approved for the treatment of fibromyalgia in Europe

remedee wristband fibromyalgia

Remedee Labs, a French start-up that specializes in non-pharmacological treatments for chronic pain has obtained medical device status in Europe for its millimeter wave endorphin stimulator wristband.  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.Our goal is for this non-pharmacological solution, the first ever approved for fibromyalgia, to quickly become a standard treatment. We will now be working with the French authorities to obtain reimbursement of our treatment, to make it affordable for everyone.
Dr David CROUZIER (PhD)
Co-founder, CEO and CSO 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 November 2023. The study’s results showed that using the Remedee™ 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.

Fibromyalgia: an invisible but severely debilitating disease

Fibromyalgia is a disorder characterized by widespread chronic pain, sleep disturbances, fatigue, and more than one hundred additional symptoms that severely alter patients’ quality of life. According to a joint report by INSERM, the French national health and medical research body, fibromyalgia affects between 1.4% and 2.2% of the French population , mainly women. Despite fibromyalgia’s serious impact on daily life, no specific treatment has been proven to be effective, so delayed diagnosis and care are very common.


Fibromyalgia has serious consequences in France, where 65% of patients report at least one sick leave from work in the past 12 months. Patients’ family and social relationships can be limited and their day-to-day activities can be disrupted, potentially leading to isolation and progressive desocialization. This impact on patients’ quality of life means that reducing their symptoms to improve their well-being is a key concern.

“This is great news for fibromyalgia patients! There is finally something really innovative in the therapeutic arsenal! Up until now, there had never been an approved treatment for fibromyalgia, even though it affects over one million people in France, especially women. The solution developed by Remedee Labs offers people living with fibromyalgia what they had long hoped for: a way to relieve their symptoms and achieve better quality of life.”
Françoise ALLIOT LAUNOIS
President of AFLAR, a French non-profit for fibromyalgia and related conditions.

Fibromyalgia: the need for multidisciplinary care

A multidisciplinary approach is key to fibromyalgia care. The first-line treatment for fibromyalgia relies on non-pharmacological approaches, mainly professionally-supervised adapted physical activity (APA), which can be combined with other non-pharmacological therapies. Psychosocial care is also important. Far from being a default option, it aims to improve pain modulation, which is altered by fibromyalgia. In most cases, it combines psychotherapy with cognitive behavioral therapy and therapeutic education. Pharmacological treatments like painkillers, antiepileptics, and antidepressants are prescribed only after the first-line treatments have been tried, and even then are temporary measures.

About the Remedee Labs solution

Remedee Labs offers an innovative, non-pharmacological solution to relieve the symptoms of fibromyalgia. The solution combines Remedee Labs’ millimeter wave neuromodulation technology (endorphin stimulator wristband) with a comprehensive support program, which is a key part of chronic pain management.

bracelet remedee
  • The Remedee™ wristband is an innovative device that uses millimeter waves (60 GHz) to stimulate the nerve endings on the inside of the wrist. The brain responds to that stimulation by releasing intracerebral endorphins which regulate the user’s perception of pain and improve their broader quality of life (sleep, fatigue, stress).

  • Alongside the wristband, the Remedee Labs offer includes human support, comprehensive digital support (advice and messaging on living better with fibromyalgia), and regular symptom tracking.

About Remedee Labs

Remedee Labs is a start-up that specializes in non-pharmacological treatments for chronic pain. Founded by three experts in medical micro- and nanotechnology and biomedical research, Remedee Labs has developed an innovative solution to improve the lives of patients suffering from chronic pain. Its solution is based on a unique technology: the first endorphin stimulator wristband.

Two clinical trials have demonstrated the effectiveness of Remedee Labs’ technology as a treatment for chronic pain caused by osteoarthritis and fibromyalgia.

Since 2022, Remedee Labs has enjoyed the support of the insurer Generali France as an investor and strategic partner. It has also partnered with the pharmaceutical company UPSA to bring healthcare professionals and their patients a comprehensive approach to chronic pain management. Today, Remedee Labs is announcing that it has obtained Medical Device status for the indication fibromyalgia, a disorder for which no specific treatment had previously been approved.

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