NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the disposable electrode that is used in conjunction with its SENSUS device. This regulatory determination by the FDA gives NeuroMetrix clearance to market the SENSUS Pain Management System in the U.S. market.
The SENSUS device is a transcutaneous electrical nerve stimulator intended for the symptomatic relief and management of chronic intractable pain in the lower leg and foot. It is a light weight, low profile device worn on the upper calf and activated by the press of a single button. It can be placed in seconds and may be worn under clothing.
"FDA clearance of the SENSUS electrode represents the last step in the regulatory pathway for the SENSUS Pain Management System," said Shai N. Gozani M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. "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. We intend to initiate the commercial launch for SENSUS before the end of the year, in line with the goal that we set over a year ago."