Denmark's °MEQU gets US FDA clearance for portable blood & IV-fluid warmer system

Danish medtech company °MEQU has announced 510(k) regulatory clearance from the US Food and Drug Administration (FDA) of the °M Warmer System, a portable blood & IV fluid warmer system for military and civilian use.
 
The patented °M Warmer Systems portable and user-friendly design enables the warming of blood and IV-fluids regardless of where the need arises, from point of injury, during transport and in the hospital, thereby reducing the risk of hypothermia in hemorrhaging patients.

The °M Warmer System meets the current Tactical Combat Casualty Care (TCCC) guidelines on providing medical care to injured military personnel in combat conditions, which highlights the use of a battery-powered warming device to deliver IV/IO resuscitation fluids to reduce the risk of hypothermia.

Leading up to the clearance numerous trials together with US military units and helicopter emergency medical services confirmed the °M Warmer Systems portability, intuitive setup and high performance. The °M Warmer System was added to the Department of Defense priority list, making it the third product on the priority list to receive FDA 510(k) clearance.