WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes reported today that it has filed a premarket notification, or 510(k), with the Food and Drug Administration (FDA) for its SENSUS Pain Therapy device.
SENSUS is a non-invasive transcutaneous electrical nerve stimulator intended to be used in the symptomatic relief and management of chronic intractable pain, such as painful diabetic neuropathy. SENSUS employs the same sophisticated nerve stimulation technology as the Company’s NC-stat® DPNCheck™ device, and includes advanced features that the Company believes may address the technical and clinical limitations of existing nerve stimulators. The device also includes technology to maximize patient compliance, which is one of the fundamental challenges with pain therapy.
Painful diabetic neuropathy affects as many as 10-20% of people with diabetes, and is a serious and disabling complication of diabetic peripheral neuropathy (DPN). The pain is typically managed pharmacologically; however, many patients remain undertreated. Recent evidence based reviews have suggested that transcutaneous electrical nerve stimulators may be useful in managing painful diabetic neuropathy.
“The filing of a 510(k) for SENSUS represents a key milestone in this product development program,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer, NeuroMetrix. “We look forward to feedback from the FDA and working towards a timely clearance. Once commercialized, we believe that SENSUS will complement NC-stat DPNCheck, our sural nerve conduction test for DPN, and move us towards our goal of creating a unique and valuable diabetic neuropathy product portfolio and franchise.”
NeuroMetrix is a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes. The Company currently markets products for the detection, diagnosis, and monitoring of diabetic neuropathies such as diabetic peripheral neuropathy and median neuropathy (carpal tunnel syndrome). For more information, please visit http://www.neurometrix.com.