The FDA typically requires warning labels for transcutaneous electrical nerve stimulators like Sensus because of their tendency to dislodge during sleep, which may pose an electrical hazard. NeuroMetrix says its Sensus system features a risk-assessment algorithm that mitigates that risk.
The Sensus device is a band worn around the lower leg and is designed specifically for patients with diabetes and chronic pain. Waltham, Mass.-based NeuroMetrix said it will re-brand and sell the product under the new indication.
"Sensus is the first and only transcutaneous electrical nerve stimulator that specifically includes use during sleep within its 510(k) indications," said CEO Dr. Shai Gozani in prepared remarks. "We will build on this expanded indication by launching a series of novel sleep enabling features for Sensus over the next 12 months."
NeuroMetrix won initial FDA clearance for the Sensus device late last year.