NeuroMetrix gains 510(k) clearance for wearable pain-relieving device to be sold OTC
WALTHAM, Mass. — NeuroMetrix on Tuesday announced that its wearable technology for treatment of chronic pain received 510(k) clearance from the Food and Drug Administration for over-the-counter use.
The company is in late-stage development of a consumer oriented chronic pain treatment product. The device is based on wearable technology, presently deployed in the company’s Sensus Pain Management System, that utilizes comfortable, non-invasive electrical stimulation of sensory nerves to induce safe and effective pain relief. It is lightweight and can be worn during the day while active, and at night while sleeping. This 510(k) clearance allows NeuroMetrix to market the over-the-counter device through retail distribution channels without a prescription requirement, the company stated.
“Patient response to Sensus, our 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,” stated Shai Gozani, president and CEO of NeuroMetrix. “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.”
Pictured is NeuroMetrix' prescription Sensus product.