The Quell device, made by NeuroMetrix, Inc. has been named a Breakthrough Device by the FDA for the treatment of fibromyalgia symptoms in adult patients. The Quell is a non-invasive, neurostimulation device used to treat the symptoms of chronic lower extremity pain. Wearable both day and night, Quell users are able to manage their treatment via a mobile app and monitor their health data, providing insights for health care providers.
According to the CDC, approximately 4 million adults in the United States suffer from Fibromyalgia, a common condition which presents symptoms of chronic pain, troubled sleep and fatigue, and cognitive disturbances. Scientists are unsure of the cause of Fibromyalgia which leads to difficulty in treating it and managing symptoms. There are FDA approved treatments but the Quell device would provide a non-pharmacological treatment option that is both safe and effective.
The purpose of the FDA Breakthrough Device Program is to highlight technologies that could provide a better treatment option for patients and help to get these devices moving through the study and approval process in a timely manner. They focus on conditions that are life threatening or permanently debilitating such as Fibromyalgia.
Now in the program, NeuroMetrix will benefit from priority review and interactive communication with the FDA as they transition from development to commercialization. “The Breakthrough Device Designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “We are moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year.”
NeuroMetrix is an innovation-driven biotechnology company focused on the development of non-invasive medical devices used in the diagnosis and treatment of pain and other neurological disorders. Their three commercial products include DPNCheck®, ADVANCE®, and Quell®.
The Quell device is a novel transcutaneous electrical nerve stimulator (TENS) that provides pain relief and management for those suffering from chronic lower extremity pain. It is available over the counter and is wearable day and night. The therapy delivered by Quell® can be personalized to manage an individual’s specific pain needs.