The US Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroMetrix's Sensus pain management system, designed as a treatment for painful diabetic neuropathy.
The Sensus system is designed for use as a non-invasive transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.
NeuroMetrix president and chief executive officer Shai Gozani said the Sensus system has attracted attention among health care providers because of its potential benefit to patients suffering from chronic pain.
"FDA clearance keeps us on track to launch the SENSUS Pain Management System in the fourth quarter of 2012," Gozani added.
"We are particularly enthusiastic about adoption of the device by diabetes focused clinicians because a number of recent systematic literature reviews and meta-analyses have concluded that transcutaneous electrical nerve stimulation may be an effective and safe treatment for painful diabetic neuropathy."