NewCardio to work closely with regulators, academia and pharmaceutical industry in the development of advanced ECG cardiac safety tools
SANTA CLARA, Calif., Jan. 22 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced it has become a member of the Cardiac Safety Research Consortium (CSRC).
The CSRC (www.cardiac-safety.org) is a broad-based collaboration of medical product safety experts from academia, industry, and the U.S. Food and Drug Administration (FDA). It was formed in 2005 in response to the Critical Path Initiative, the FDA's premier effort to modernize the drug development process. The CSRC's primary goal is to facilitate development of new tools to improve cardiac safety assessment of medical products, especially tools to quantify arrhythmia (abnormal heart beat) risk of new drugs in development. With the FDA, the CSRC established a centralized ECG warehouse of ECGs obtained from drug clinical research studies.
NewCardio intends to be an active participant in CSRC efforts, by providing expertise and technology as needed, and by conducting targeted research and development projects, as such projects are reviewed and approved by the CSRC's Scientific Oversight Committee.
Branislav Vajdic, PhD, NewCardio's Chief Executive Officer, commented, "Both NewCardio and the CSRC are firmly committed to the goals of the FDA's Critical Path Initiative, the most important of which is to develop new technology to improve cardiac safety of drugs and other medical products. We regard membership in the CSRC as an important event in advancing our mutual goals, and we look forward to active and productive participation in CSRC efforts."
Mitchell W. Krucoff, MD, Professor of Cardiovascular Medicine at
|SOURCE NewCardio, Inc.|
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