SIGNAL HILL, Calif., Sept. 1 /PRNewswire/ -- Integrated Medical Systems, Inc., a medical technology systems integrator transforming critical care, announced that it has received CE Mark certification for the company's MedEx 1000(TM) "suitcase" intensive care unit (ICU). This certification, administered by the company's Notified Body, VTT (Finland), permits the marketing, sale and use of the MedEx 1000 in Europe.
"Receipt of the CE Mark certification is an essential step to meet the growing global demand for fully integrated solutions generally, and for the MedEx 1000 specifically," said Todd Kneale, president and chief operating officer of Integrated Medical Systems, Inc. "This allows us to begin shipments to key European customers. I'm very proud of our team, especially our director of regulatory affairs, Dr. Renate MacLaren." MacLaren notes, "This certification is the result of a team effort involving not just the IMS team, but of our suppliers and partners, and builds on our previous regulatory accomplishments."
In reviewing the company's application for CE Mark, VTT auditor, Seppo Lavonen, observed "The documentation you provided is one of the best I have seen."
About the MedEx 1000
The MedEx 1000 is a portable unit intended to supply ICU functionality for adult and pediatric patients. The MedEx 1000 combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities and the ability to deliver oxygen to a patient. The functions of the MedEx 1000 are controlled from a central user interface. The MedEx 1000 may be operated using either hot-swappable battery power or
|SOURCE Integrated Medical Systems, Inc.|
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