Health Canada Approves Avacen’s Non-Drug Treatment Device for Fibromyalgia Pain

Health Canada Approves Avacen’s Non-Drug Treatment Device for Fibromyalgia Pain
Avacen Medical says its Avacen 100 Class-II medical pain treatment product has received a medical device license from Health Canada to treat fibromyalgia. The San Diego-based biotech firm's marquee product uses a non-invasive technique for safely infusing heat into the body's circulatory system. Avacen says its device relaxes muscles while increasing microcirculation throughout the body, and that unlike other local pain relief medical devices, the Avacen 100's proprietary action mechanism provides widespread, systemic pain relief. CEO Thomas Muehlbauer described the device in a press release as "the only OTC [over-the-counter] medical device on the market today able to provide non-invasive, rapid whole body treatment, using a single point of contact. It is the ideal drug-free and safe alternative for relief of muscle and joint pain." The device is not for sale in the United States, Canada, Europe or India for the treatment of any non-cleared or non-approved indication. Canadian federal and provincial healthcare officials are worried about the growing number of opioid drug-related deaths, partly from street fentanyl but also from the abuse of legal prescription painkillers. "The most exciting aspect of this approval is that the Canadian market has shown high demand and acceptance for innovative new alternatives to pharmaceuticals for treating pain." said Muehlbauer, whose company already has 
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