WElkins Receives FDA 510(k) Clearance
New device enables ultra-early, non-invasive therapeutic hypothermia in the field
ROSEVILLE, CA, August 23, 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 care—from the critical minutes after an injury thru to the ICU and recovery. Therapeutic cooling is among the most potent interventions for hypoxic-ischemic injury, limiting tissue damage by reducing oxygen metabolism and inflammation, while maintaining cell membrane integrity. 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.