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 an external source. The unit can accept external high pressure or low pressure sources of oxygen. A USB Port provides connectivity to an external printer, and allows for a connection of a USB flash drive to off-load (download) logged data. An Ethernet Port allows for Local Area Network (LAN) connectivity. The MedEx 1000 is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities. A future upgrade will allow additional medical devices to be added using the Auxiliary Device Port and be controlled and displayed through the MedEx 1000.
The purpose of the MedEx 1000 is to help support continuous patient care during transport from outside of the hospital or within the hospital environment. Current practice includes frequently disconnecting and reconnecting a patient from therapy and monitoring when a patient is transported. During transport, caregivers have to juggle multiple medical devices and when they arrive at a destination, connect the devices to a central computer. Use of the MedEx 1000 not only increases patient safety, but caregiver efficiency, as well. Clinical studies with the predicate device, the LSTAT(TM) stretcher-based integrated patient care platform, demonstrated the need for fewer caregivers during transport, faster response time to adverse events, faster 'time to go' between wards, and potential reduction in the hospital length-of-stay ("Life Support for Trauma and Transport: a mobile ICU for safe in-hospital transport of critically injured patients", Velmahos et al, Journal of the American College of Surgeons, 2004 July;199 (1):62-8).
About Integrated Medical Systems
Integrated Medical Systems, Inc. (IMS) is the leading innovator in the development of fully integrated products for critical care. Our firm, whose principal shareholders include Northrop Grumman Corporation (NGC), is committed to the rapid deployment of products that include portable intensive care systems, advanced diagnostic and therapeutic devices, telemedicine networks, and related information systems. For more information on IMS and the MedEx 1000 "suitcase ICU", please visit www.medex1000.com.
|SOURCE Integrated Medical Systems, Inc.|
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