A Diagnostics & Imaging Week
Integrated Medical Systems (IMS; Signal Hill, California), a developer of integrated products for critical care, reported FDA clearance for its MedEx 1000 "suitcase" intensive care unit (ICU).
The MedEx 1000 is a portable unit intended to supply ICU functions for adult and pediatric patients, combining several medical device capabilities in 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.
The functions of the MedEx 1000 are controlled from a central user interface; it 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.
The MedEx 1000 is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities.
"FDA clearance of the MedEx 1000 is a major accomplishment for the company as we continue to demonstrate the economic and clinical value of integrated patient care technologies," said Todd Kneale, president/COO of IMS. He called the clearance significant because received "in less than 60 days from submittal of the application [and] includes the company's new modular integrated architecture that will serve as a basis for an entire product family of scalable, customizable integrated solutions, and includes the first centralized control — as well as the first remote control — of multiple medical, data and utility capabilities."