NeuroMetrix, a medical device firm, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Sensus Pain Management System, a transcutaneous electrical nerve stimulator that can be used by diabetics during sleep.
Designed as lightweight, convenient and wearable, this non-invasive device acts as non-narcotic pain relief option for people suffering with diabetes.
It can be worn during the day and complements medications.
The company claimed that this is the only transcutaneous electrical nerve stimulator, designed particularly for diabetics who endure chronic pain.
One of the most common reasons for chronic pain in diabetics is the painful diabetic neuropathy (PDN), a condition that affects around five million people in the US, and about 50% of the patients who have this condition suffer from improper sleep, which in turn could worsen their diabetes.
Following the regulatory approval, this stimulator may be sold for overnight use.
According to the FDA draft guidance, transcutaneous electrical nerve stimulators for pain relief should indicate a warning against use during sleep, mainly due to electrical risks as result of electrodes dislodgement.
However, Sensus addresses this issue by making use of a proprietary electrode peeling detection algorithm.
NeuroMetrix CEO and president Dr Shai N Gozani noted that SENSUS is the first and only transcutaneous electrical nerve stimulator that specifically includes use during sleep within its 510(k) indications.
"We believe that growing recognition of the inter-relationship between chronic pain, such as painful diabetic neuropathy, and sleep disturbances is clinically important and represents a unique market position for SENSUS," Gozani said.
"We will build on this expanded indication by launching a series of novel sleep enabling features for SENSUS over the next 12 months."