The clearance allows Waltham, Mass.-based NeuroMetrix to sell the device directly to consumers without a doctor’s prescription, according to a press release.
"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," president & CEO Dr. Shai Gozani, said in prepared remarks. "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."
The Sensus device, which won 510(k) clearance from the FDA in 2012, uses non-invasive electrical stimulation of sensory nerves to alleviate pain.
The OTC version of the device is in "late-stage development," the company said.
The news sent NURO shares surging 35.5% to $2.56 apiece today as of about 10:30 a.m.