NeuroMetrix, Inc., based in Waltham, MA, reported regulatory approval in China for DPNCheck, a diagnostic test for peripheral neuropathy. DPNCheck is now registered as a Class II Medical Device under the Regulations for the Supervision and Administration of Medical Devices of the China Food and Drug Administration (CFDA). Regulatory approval allows DPNCheck to be marketed in China.
DPNCheck is a rapid, accurate and quantitative point-of-care test to detect diabetic peripheral neuropathy, or DPN, at an early stage allowing physicians to select appropriate treatment. DPN is the most common complication of diabetes, affecting over half of people with diabetes. DPN causes significant morbidity including pain, increased risk of falling in the elderly, and is the primary trigger for diabetic foot ulcers which may require lower extremity amputations.
China is dealing with an epidemic of diabetes. According to a recently published study in the Journal of the American Medical Association (JAMA), the prevalence of diabetes in the Chinese population has risen dramatically over the past decades to 11.6% today. The International Diabetes Federation (IDF) estimated in 2014 that over 96 million people in China had diabetes. This represents nearly 25% of the IDF estimated worldwide population of 387 million people with diabetes.