CAS Medical Systems, Inc., a leader in medical devices for non-invasive patient monitoring, today announced that its FORE-SIGHT Cerebral Oximeter has been approved by the China Food and Drug Administration (CFDA) for sale in that country. FORE-SIGHT is the only cerebral oximeter manufactured outside China to have approval from the CDFA.
"The CFDA approval is the culmination of a three-year testing and approval process and reflects the strength of our technology and recognition of the importance of cerebral oximetry to the Chinese medical community," said Thomas M. Patton, President and Chief Executive Officer of CASMED. "With this approval, our distribution partner, Beijing Gloryway Medical, will immediately begin selling FORE-SIGHT to its Chinese customers. Our target market is the approximately 800 Level 3A hospitals that are the premier medical institutions in the country. Although we do not foresee significant sales in China in the near term, the CFDA approval is an important part of our strategy to expand into large markets outside of the United States where we do not currently have FORE-SIGHT distribution."
Beijing Gloryway Medical Co., Ltd. has approximately 30 sales representatives in branch offices across China. The company has been distributing high-quality, imported medical products to anesthesiologists in China since 2000.
Mr. Patton added, "According to a report by iData Research, a number of factors are contributing to increased cardiovascular surgery in China, including the growth of the overall economy, greater public access to medical professionals and hospitals, and a rise in Western diets; the latter is leading to a specific increase in coronary artery bypass graft (CABG) procedures. The demand for cardiac surgery equipment in China is expected to grow by 13% per year from 2011 to 2018."