Integrated Medical Systems, Inc., a medical technology systems integrator developing fully integrated products for critical care, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its MedEx 1000(TM) "suitcase" intensive care unit (ICU).
"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 and Chief Operations Officer of Integrated Medical Systems, Inc. "This clearance is significant because it was received in less than 60 days from submittal of the application, 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. Just like systems integration transformed the automotive, aerospace and computer industries, the company is at the forefront of transforming healthcare through systems integration."
"We believe this innovative system addresses a large unmet clinical need to support continuous patient care," said Adam Seiver, MD, PhD, Adjunct Clinical Associate Professor of Surgery Medical School, Stanford, former Director of Surgical Critical Care at Stanford Medical Center, and a member of company's Board of Advisors.
The MedEx 1000 is the first hand-portable integrated medical, data and utility suite. Caregivers will now be able to provide continuous care, never needing to disconnect and re-connect a patient from therapy and monitoring as the patient is moved throughout a hospital, or even pre-hospital transport or disaster response. This technology meets a key need to increase patient and caregiver safety, while at the same time reducing the weight, volume, cost and clutter of current equipment.