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www.fdanews.com/articles/165689-fda-grants-510k-clearance-to-neurometrixs-wearable-chronic-pain-relief-device

FDA Grants 510(k) Clearance to NeuroMetrix’s Wearable Chronic Pain-Relief Device

July 8, 2014

Waltham, Mass., devicemaker NeuroMetrix said Tuesday that its wearable device for the treatment of chronic pain has been FDA-cleared for over-the-counter use.

The unnamed device uses wearable technology currently featured in the company’s prescription-only Sensus Pain Management System, which electrically stimulates the sensory nerves, resulting in safe and effective pain relief, according to NeuroMetrix. The lightweight device can be used to deliver noninvasive stimulation during regular daily activities and at night while the patient is sleeping.

NeuroMetrix president and CEO Shai N. Gozani said the ability to offer both a prescription and OTC wearable pain-relieving device will allow the company to reach more people suffering from chronic pain.

The OTC device is in currently in late-stage development and set for commercial launch in 2015, Gozani added. The Sensus system was launched in the U.S. last year. — Kellen Owings

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