Danish MedTech company °MEQU announces 510(k) received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the °M Warmer System – a portable blood & IV fluid warmer system for military and civilian use.
“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. 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.”
– Ulrik Krogh Andersen, Founder & CEO of °MEQU.
A PORTABLE SOLUTION THAT WARMS BLOOD WHERE THE NEED ARISES
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 was initially developed in collaboration with the Danish military and the Technical University of Denmark (DTU) to reduce hypothermia and improve the survival and recovery rate of severely injured 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.1
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.
The °M Warmer System is adopted in both 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, where great interest has already been confirmed.
1 https://tccc.org.ua/files/downloads/clinical-guidelines-2024-en.pdf – section 7,h