Mequ announced today that the FDA granted 510(k) clearance to its M Warmer system, a portable blood and IV fluid warmer platform.
The Copenhagen, Denmark–based medtech company offers the warmer for both military and civilian use. It features a portable, user-friendly design that enables the warming of blood and IV fluids regardless of location. That includes point of injury, during transport and in the hospital.
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Mequ originally developed the M Warmer system in collaboration with the Danish military and Technical University of Denmark. It aimed to reduce hypothermia and improve the survival and recovery rate of severely injured patients. The battery-powered system meets current Tactical Combat Casualty Care (TCCC) guidelines to warm resuscitation fluids and reduce hypothermia.
According to a news release, Mequ conducted numerous trials with U.S. military units and helicopter emergency medical services. The U.S. Defense Deptartment added the M Warmer to its priority list, making it the third product on that list to receive FDA 510(k) clearance. Mequ plans to accelerate commercial activities in the U.S. market with its new clearance.
“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,” said Ulrik Krogh Andersen, founder & CEO of Mequ.
