NeuroMetrix, a US-based medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its transcutaneous electrical nerve stimulator, called Sensus Pain Management System.
Sensus Pain Management System is a wearable non-invasive device that provides non-narcotic pain relief option to patients and complements medications.
NeuroMetrix president and CEO Dr. Shai Gozani said 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 added.
Designed for people with diabetes and chronic pain, the device is a lightweight transcutaneous electrical nerve stimulator which can be worn during the day when patients remain active.
It is observed that nearly half of the painful diabetic neuropathy patients suffer from sleep disturbances, which can increase their diabetes.
Under the draft guidance on transcutaneous electrical nerve stimulators for pain relief, the FDA has permitted such devices to carry a warning against use during sleep, initially due to electrical hazards subsequent to the dislodgement of electrodes.
In order to address this risk, Sensus is designed with an electrode peeling detection algorithm.