FDA Grants Breakthrough Device Designation for groundbreaking Fibromyalgia Management Device

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A May 12, International Fibromyalgia Awareness Day, press release at Cision PR Newswire announced the FDA has granted Breakthrough Device Designation to a new French business named Remedee Labs for its endorphin stimulator as a potential tool for the management of Fibromyalgia. The press release states that "this designation recognizes both the highly innovative nature of Remedee's device and its potential benefits for fibromyalgia patients adjunctively with standard of care. Obtaining Breakthrough Device status is a strong first step toward US market authorization."[1]

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Endnotes:

[1] FDA Grants Breakthrough Device Designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of Fibromyalgia

Cision PR Newswire

Press Release

May 12, 2022