Thursday, October 2, 2008

NeuroMetrix granted FDA clearance for electrodes

By Mass High Tech Staff

Waltham medical devices firm NeuroMetrix Inc. has been granted 510(k) clearance from the U.S. Food and Drug Adminsitration for three of the company’s Universal Electrodes. The single-patient, disposable electrodes are used in nerve conduction studies, in conjunction with the company’s Advance NCS/EMG System.

The FDA-cleared electrodes, not intended for specific nerves or limbs, include the Universal Stimulator Bar Electrode for peripheral nerve stimulation and the Universal Tab and Ring Electrode Sets used to record peripheral nerves’ motor and sensory response. Included in the electrodes are an embedded digital thermometer to check skin surface temperature; flexible printed circuits to integrate electrical traces and hydrogels; single keyed connection to avoid connection problems; and packaging that preserves electrode functionality.

In July, NeuroMetrix (Nasdaq: NURO) filed regulatory documents that enable it to begin sales of its “Advance” system used in nerve conduction studies and electromyography procedures in the European Union. The company received U.S. market clearance for the Advance system in April.

NeuroMetrix, which develops and sells medical devices used in procedures for patients with peripheral nerve damage and other neurological conditions, reported a 2007 net loss of $8.4 million on revenue of $44.6 million.