FDA OKs °MEQU’s Portable Blood and IV Fluid Warmer

Danish medtech company °MEQU has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its °M warmer system, a portable blood and IV fluid warmer for military and civilian use.
 
The system provides blood and IV fluid warming from point of injury, during transport, and in the hospital. This lowers the risk of hypothermia in hemorrhaging patients.
 
It was developed in partnership with the Danish military and the Technical University of Denmark (DTU) to reduce hypothermia and improve severely injured patients’ survival and recovery rate. The °M warmer meets current Tactical Combat Casualty Care (TCCC) guidelines on providing medical care to injured military personnel in combat conditions.
 
°MEQU said numerous trials with U.S. military units confirmed portability, intuitive setup, and performance. The °M warmer was added to the Department of Defense’s priority list, the third item on the priority list to earn FDA clearance.
 
The system is adopted in Helicopter emergency medical services, emergency medical services, hospitals and defense forces across Europe and Australia. With the FDA clearance, °MEQU can now accelerate their commercial activities in the U.S. market.
 
“We are proud to receive the FDA clearance, which is a major milestone for our company and the result of more than 10 years of product development,” said °MEQU founder and CEO Ulrik Krogh Andersen. “With the clearance the road is paved for a strong presence in the U.S. market, and we are honored to be able to help U.S. healthcare professionals in their efforts to save lives with our °M Warmer System.”