NeuroMetrix Inc., a Waltham-based medical device company, said it has gotten regulatory clearance to market a device that helps manage chronic pain in the lower leg or foot.
The device is called the SENSUS Pain Management System, and it’s a lightweight electrical nerve stimulator that is worn on the upper calf and activated by the press of a button. According to the company’s website, trancutaneous electrical nerve stimulation has been shown to provide pain relief for patients with diabetes.
In its press release, NeuroMetrix said that it has received 510(k) clearance from the Food and Drug Administration 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 US market, the company said.
In a statement, company president and chief executive Shai N. Gozani said: “FDA clearance of the SENSUS electrode represents the last step in the regulatory pathway for the SENSUS Pain Management System. 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.”