NeuroMetrix, Inc. has submitted a CE technical file application for its Quell pain management device to TŰV SŰD Product Service GmbH, which is one of the European bodies responsible for reviewing and approving new products.
The regulatory filing seeks Quell CE certification in the European Union as a class IIa medical device. If approved, the CE certification would allow Quell to be marketed directly to consumers within the European Union.
Recent epidemiological studies indicate that 20-40 percent of the adult European population suffers from chronic pain, with an annual financial cost exceeding $250 billion. The impact of chronic pain extends beyond the direct effects of pain to include disturbed sleep, low activity, mental health issues, cardiovascular disease and generally poor health.
“Europe is the natural market for initial international expansion of Quell sales,” Shai N. Gozani, MD, PhD, president and CEO of NeuroMetrix, said in announcing the application. “Today we are focused on North America. However, our longer term strategy is to make Quell available in all markets with a high prevalence of chronic pain.”
With the filing for CE Marking, the company plans to hold partnership and distribution discussions for anticipated market entry in 2017, according to Gozani.
The lightweight Quell wearable device is can be worn during the day while active and at night while sleeping, according to the company. Designed for people suffering from chronic pain, it has been cleared by the FDA for treatment without a prescription.