Navigation Links
Integrated Medical Systems Receives FDA Clearance for World's First 'Suitcase' Intensive Care Unit
Date:10/13/2008

SIGNAL HILL, Calif., Oct. 13 /PRNewswire/ -- 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.

Initial deliveries of the MedEx 1000 are expected in the first quarter of 2009. IMS expects to have a CE Mark by fall 2008, permitting marketing and sales in Europe.

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 http://www.medex1000.com


'/>"/>
SOURCE Integrated Medical Systems, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Health Integrated to Showcase Synergy Personal Health Management(R) at DMAA Conference
2. Hooper Holmes Launches Health & Wellness Division at 2007 Disease Management Leadership Forum and Integrated Care Summit
3. LMS integrated obstetrics solution achieves general availability
4. The Integrated Benefits Institute Offers Largest Benchmarking Database in U.S. Spanning Disability and Workers Compensation Programs
5. California Physician Groups Recognized by Integrated Healthcare Association (IHA)
6. Solano Regional Medical Group and Sutter Regional Medical Foundation Recognized by Integrated Healthcare Association (IHA)
7. Halogen Offers Performance Based Integrated Learning Management System
8. Publicis Groupe Strengthens its Leadership in Digital and Integrated Healthcare Communications in Italy
9. Excerpta Medica and Elsevier Interactive Solutions merge into 1 integrated provider
10. Medsphere & Keane Join Forces to Provide Healthcare Enterprises With Integrated Electronic Health Record & Revenue Cycle Management Systems
11. Integrated approach to IMRT provides quality care for head and neck cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and Nutrition ... the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market ... can be easily incorporated into liquid products, while reducing costs to end users. , ...
(Date:10/13/2017)... OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... or dementia. However, many long-term care insurance companies have a waiver for care if ... the 90-day elimination period, when the family pays for care, is often waived, so ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The ... the most popular and least understood books in the Holy Scriptures, Revelation. The Book ... have baffled scholars for centuries. Many have tossed it off as mere rubbish, but ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the loss ... author, William Nowers. Captain Nowers and his wife, Millie, have six children, ten ... the Navy. Following his career as a naval aviator and carrier pilot, he ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/4/2017)... , Oct. 4, 2017  According to the Centers for Disease ... end of October . PhysicianOne Urgent Care is helping communities across ... Westchester, NY , by offering no-cost* flu shots through the end ... mandated by certain health insurance regulations. ... The best time to get a flu shot is by the end ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and Company ... results for the third quarter of 2017 on Tuesday, ... call on that day with the investment community and ... The conference call will begin at 9 a.m. ... access a live webcast of the conference call through ...
Breaking Medicine Technology: