NeuroMetrix lands FDA OK for Sensus pain management system

December 3, 2012 by MassDevice staff

The FDA OKs NeuroMetrix's Sensus pain management system for the U.S. market.

NeuroMetrix logo

NeuroMetrix (NSDQ:NURO) landed FDA clearance for its Sensus pain management system, a non-invasive transcutaneous electrical nerve stimulator designed to relieve the symptoms of diabetic neuropathy.

The Sensus pain management system offers relief and management of chronic intractable pain in the lower leg and foot. Patients can wear the device under clothing thanks to its light weight and low profile, according to NeuroMetrix.

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"FDA clearance of the Sensus electrode represents the last step in the regulatory pathway for the Sensus pain management system," president & CEO Dr. Shai Gozani said in prepared remarks. "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."

NeuroMetrix filed its 510(k) application for the system in April.

The company plans to launch the Sensus system commercially before the end of this year, Gozani said.