NeuroMetrix, a medical device company based in Waltham, Massachusetts, received clearance from the United States Food and Drug Administration for its Sensus pain management system. The Sensus pain pain management system is comprised of a specialized transcutaneous nerve stimulator that provides relief from the painful side effects of diabetic neuropathy.
According to a press release by the company, the Sensus pain management system is designed to provide relief from chronic pain in the foot and lower leg. The portable device can be worn under the clothing due to its low profile and minimal weight. With portable operation, patients can receive relief from pain outside of healthcare facilities or residential environments.
The company first filed a 510(k) application for its Sensus pain management system in April of this year. According to information released by the company, NeuroMetrix plans to launch the Sensus system by the end of 2012.
Dr. Shai Gozani is CEO and president at Neurometrix. In a prepared statement, he said, "FDA clearance of the Sensus electrode represents the last step in the regulatory pathway for the Sensus pain management system.” He continued, "We believe that physicians treating patients with painful diabetic neuropathy, a severe and debilitating form of chronic pain, will find Sensus to be a useful therapeutic option."
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