NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a “premarket notification” of a company’s intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.
SENSUS is a “transcutaneous electrical nerve stimulation” device that works by sending low-voltage currents to nerves through electrodes attached to the skin. In diabetic neuropathy, nerves become inflamed and damaged over time from high blood sugar levels. Studies have shown that many people afflicted with neuropathy enjoy relief from pain when affected nerves receive electric stimulation.
Up to 20 percent of people with diabetes suffer from diabetic neuropathy. If the condition is advanced, they can experience extreme pain and loss of mobility. Physicians usually treat the condition with drugs, which have varying degrees of effectiveness. NeuroMetrix says that eventual FDA approval of SENSUS will make available another mode of pain management.