WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 29, 2006--NeuroMetrix, Inc. (Nasdaq: NURO - News), a medical device company focused on the development and sale of proprietary products that help physicians diagnose neuropathies, including carpal tunnel syndrome and diabetic peripheral neuropathy, announced today that it has received an updated FDA 510(k) clearance for its NC-stat nerve conduction testing system.
In this FDA 510(k) clearance (K060584, www.fda.gov/cdrh/pdf6/k060584.pdf), the Intended Use has been updated and a new version of the NC-stat median nerve biosensor has been cleared.
The updated Intended Use language is “The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.” Furthermore, Section 6 (Basis for Substantial Equivalence) of the 510(k) Summary states “Clinical data submitted in the 510(k) demonstrates that nerve conduction measurements obtained using the NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment.”
Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer, commented: “Our latest FDA clearance further reinforces our market leadership position and the clinical value we consistently deliver to over 12,000 physicians and the patients they diagnose and care for with the NC-stat System. The NC-stat is the only automated nerve conduction system that has received FDA clearance as equivalent to conventional nerve conduction studies. It is important to note that other products have limited marketing clearance and are not equivalent to conventional measurements. Our superior regulatory status is founded upon the proven clinical and technical validity of the NC-stat, which has been documented in over 35 articles in peer-reviewed journals and abstracts at major medical conferences.
Dr. Gozani continued: “This latest version of the median nerve biosensor will enhance testing of the median nerve while maintaining the proven diagnostic accuracy of the original biosensor design. With the addition of this biosensor, we have further solidified the NC-stat as the most advanced nerve conduction testing system on the market.”
About NeuroMetrix
NeuroMetrix is a medical device company that is establishing a new standard of care through the design, development and sale of proprietary products that help physicians diagnose neuropathies. Neuropathies are diseases of the peripheral nerves and parts of the spine that frequently are caused by or associated with diabetes, low back and leg pain and carpal tunnel syndrome, as well as other clinical disorders. The NC-stat System, the Company’s neuropathy diagnostic system, has been on the market since May 1999 and is presently used in over 4,000 physician’s offices and clinics in the United States. The Company holds issued utility patents covering a number of important aspects of the NC-stat System.
Contact: NeuroMetrix, Inc. Brad Smith, 781-890-9989 NeuroMetrix.ir@NeuroMetrix.com
Source: NeuroMetrix, Inc.
