Neuromod secures CE Mark for mutebutton
Irish Medical Devices company Neuromod Devices (www.NeuromodDevices.com) today announced it has successfully secured the CE Mark for mutebutton®, (www.mutebutton.ie) securing regulatory approval for this new multisensory neuromodulation device within the European Union.
“The medical device CE Mark is required for the approved sale of any medical device in Europe. It certifies the safety and efficacy of a product and the competency of the manufacturer in being able to bring an approved medical device to market. In the absence of readily available treatments, many tinnitus sufferers try less effective treatments. Many even try products or services, which are sold without the necessary regulatory approval. We are delighted to have secured our medical device CE Mark for mutebutton®, which certifies the safety and efficacy of the device and Neuromod’s capability as a credible medical device manufacturer.” CEO Dr. Ross O’Neill
Tinnitus affects 10% of the UK population, according to the British Tinnitus Association, with 1% reporting significant secondary symptoms such as sleep deprivation, anxiety and depression. At present there are limited avenues of treatment for subjective tinnitus sufferers and medical professionals alike.
Neuromod Devices is headquartered in NovaUCD, the Centre for New Ventures and Entrepreneurs at University College Dublin (UCD). The company anticipates the Irish launch of the mutebutton® system in Dec 2014.