CAS Medical Systems, a manufacturer of medical devices for non-invasive patient monitoring, has obtained an approval from the China Food and Drug Administration (FDA) for its FORE-SIGHT cerebral oximeter.
CAS Medical Systems claims that FORE-SIGHT is the only cerebral oximeter manufactured outside China to have approval from the FDA.
CAS Medical Systems president and CEO Thomas M Patton noted the FDA approval is the culmination of a three-year testing and approval process and reflects the strength of the company’s technology and recognition of the importance of cerebral oximetry to the Chinese medical community.
"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," Patton added.
Beijing Gloryway Medical has been distributing imported medical products to anesthesiologists in China since 2000.