NeuroMetrix, a medical device company focused on the treatment and management of the neurological complications of diabetes, has reported the regulatory submission for NC-stat DPNCheck in Japan.
NC-stat DPNCheck is a fast, accurate and quantitative test based on sural nerve conduction that may be used to evaluate neuropathies such as diabetic peripheral neuropathy (DPN) at an early stage allowing physicians to select appropriate treatment.
The DPNCheck test is designed to address an unmet medical need for better and more cost-effective screening, diagnosing and monitoring of DPN.
DPN is the most common complication of diabetes that affects over 50% of people with diabetes and leads to foot ulcers and limb amputation, as well as severe pain and an overall reduction in patient quality of life.
The submission was prepared in close collaboration with Omron Healthcare, NeuroMetrix’s partner for NC-stat DPNCheck in Japan and other Asia markets.
The submission seeks marketing certification for a Class II Designated Controlled Medical Device as defined in the technical standards of the Japan Ministry of Health, Labor, and Welfare.
Earlier in January 2014, the company also launched a website in the US to support growing NC-stat DPNCheck business.