NeuroMetrix, a developer of wearable medical technology and point-of-care tests, has obtained the US Food and Drug Administration’s (FDA) 510(k) clearance for its wearable technology for over-the-counter (OTC) use in the treatment of chronic pain.
Currently, NeuroMetrix is in late stage development of a consumer oriented chronic pain treatment product, which is based on its wearable technology. At present, the wearable technology is deployed in the company’s Sensus pain management system.
The Sensus pain management system uses comfortable, non-invasive electrical stimulation of sensory nerves to induce safe and effective pain relief. The device can be worn during the day while active, and at night while sleeping.
NeuroMetrix president and CEO Shai Gozani said that patient response to Sensus, the company’s prescription wearable device for treatment of chronic pain, has been very positive since it was launched in early 2013.
"We believe that there is a substantial consumer market for an over-the-counter version of this technology," Gozani added.
"The ability to offer both prescription and over-the-counter products will give us maximal market exposure and allow us to reach more people with chronic pain. We anticipate a commercial launch in 2015."