NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, has received 510(k) clearance from the U.S. FDA for the disposable electrode that is used in conjunction with its Sensus device.
NeuroMetrix develops and markets home use and point-of-care devices, associated consumables, and support software for the treatment and management of diabetes and its complications. The company is focused on nerve related complications of diabetes, called diabetic neuropathies, which affect over 50% of people with diabetes.
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.”
Source: NeuroMetrix, Inc., Business Wire