Remedee Labs, a French start-up focused on non-pharmacological treatments for chronic pain, has announced that its millimeter wave endorphin stimulator wristband has officially been granted medical device status in Europe.

This makes it the first clinically validated and certified device in Europe designed to provide symptom relief for fibromyalgia, a condition previously without specific treatments. This milestone offers new hope for millions of patients suffering from the disorder.

"Securing European medical device status for fibromyalgia is a pivotal moment for Remedee Labs and, more importantly, for those living with the condition who have lacked approved and targeted treatment options," said Dr. David Crouzier, co-founder and CEO of Remedee Labs.

The device’s certification is supported by results from the FIBREPIK clinical trial, which were presented at the American College of Rheumatology (ACR) annual meeting in 2023.

The study showed that using the Remedee™ wristband three times a day for 30 minutes significantly improved participants' quality of life, with reductions in pain, fatigue, anxiety, depression, and improvements in sleep.

Additionally, Remedee Labs’ device has been recognized in the U.S., where it received Breakthrough Device Designation from the FDA in 2022.

The company plans to launch its fibromyalgia-focused medical offering in France by 2025.




Source: prnewswire.com

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