NeuroMetrix has filed Sensus pain therapy device's 510(k) application with the US Food and Drug Administration (FDA).
Sensus is a non-invasive transcutaneous electrical nerve stimulator which is designed to be used in the symptomatic relief and management of chronic intractable pain such as painful diabetic neuropathy.
Sensus device utilizes company’s nerve stimulation technology as the NC-stat DPNCheck device and also include a technology to maximize patient compliance.
NeuroMetrix president and chief executive officer Shai Gozani said the company is looking forward for feedback from the FDA and working towards a timely clearance.
"Once commercialized, we believe that SENSUS will complement NC-stat DPNCheck, our sural nerve conduction test for DPN, and move us towards our goal of creating a unique and valuable diabetic neuropathy product portfolio and franchise," Gozani added.