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WElkins Receives 510(K) Clearance from FDA for EMT/ICU Temperature Management System

ROSEVILLE, CA (PRWEB) August 27, 2012

WElkins, LLC today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EMT/ICU Temperature Management System. The EMT/ICU System provides hospitals and emergency care givers a means of reducing and controlling patient temperature in a safe, non-invasive, and effective way across the continuum of carefrom the critical minutes after an injury thru to the ICU and recovery. The System includes a lightweight, portable cooling unit for pre-hospital induction of therapeutic cooling, i.e. immediately after return of spontaneous circulation (ROSC), which can be crucial to patient survival and recovery. Therapeutic cooling is one of the most critical interventions for hypoxic-ischemic injury, limiting tissue damage by reducing oxygen metabolism and inflammation, while maintaining cell membrane integrity.

We are very pleased to receive FDA market clearance for the EMT/ICU System, which is the first in a series of new microenvironment cooling products WElkins will be introducing over the next year to our civilian and military clients, said Christopher Blodgett, Chief Operating Officer of WElkins. With these devices, WElkins will introduce a new standard in patient temperature managementone that extends active cooling technology to the pre-hospital setting for those critical moments after an injury, in the field and during transit, all the way through to the ICU and recovery. Therapeutic hypothermia has the potential to save lives and limit long-lasting neurological damage. We are very excited to see the EMT/ICU System on the market and this represents an important first-step in WElkins mission to transform human survival and quality life.

WElkins plans to launch the EMT/ICU System in the U.S. immediately and will expand to global markets early next year.

About the EMT/ICU Temperature Management System

The EMT/ICU Temperature Management System is a family of non-invasive, liquid-cooled, thermoregulatory devices that control patient temperature within a range of 30

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