Massachusetts-based Neurometrix just received 510(k) clearance from the Food and Drug Administration for over-the-counter use of its wearable gadget that treats chronic pain.
The lightweight device, which is still under development and projected for commercial launch next year, emits electric jolts to the wearer.
It is modeled after Sensus, the company’s device that treats pain associated with diabetic neuropathy. The microcap public company’s Sensus received FDA approval in 2012 and launched in early 2013.
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“We believe that there is a substantial consumer market for an over-the-counter version of this technology,” Neuromatrix President and CEO Shai Gozani said in a statement. “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.”
[Image of Sensus device courtsey of Neurometrix]