NeuroMetrix, Inc. NURO, www.neurometrix.com, a medical device
company focused on the diagnosis and treatment of the neurological
complications of diabetes, reported that it has received 510(k) clearance from
the U.S. Food and Drug Administration (FDA) for the disposable electrode that
is used in conjunction with its SENSUS device. This regulatory determination
by the FDA gives NeuroMetrix clearance to market the SENSUS Pain Management
System in the U.S. market.
The SENSUS device is a transcutaneous electrical nerve stimulator intended for
the symptomatic relief and management of chronic intractable pain in the lower
leg and foot. It is a light weight, low profile device worn on the upper calf
and activated by the press of a single button. It can be placed in seconds and
may be worn under clothing.
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