Danish medical technology firm °MEQU has received 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its innovative portable blood and IV fluid warmer system, °M Warmer System, designed for both civilian and military use.
According to Ulrik Krogh Andersen, Founder & CEO of °MEQU, the approval of the company’s product is a significant milestone attributed to more than a decade of research and product development. The approval paves the way for °MEQU’s presence in one of the world’s largest markets, aiding healthcare professionals in saving more lives.
°MEQU’s °M Warmer System is a single-patient use blood IV-fluids warming system that allows for blood warming whenever needed. This system is a product of collaboration between the Danish military and the Technical University of Denmark (DTU) to help improve injured personnel’s survival rate and recovery.
Due to its portability and user-friendliness design, it can be used for both civilian and military purposes, from the point of injury, during transport, including on helicopters, airplanes, and hospitals. The system can help reduce hypothermia in hemorrhaging patients, helping save lives.
°MEQU °M Warmer System
The whole system takes less than 30 seconds to set up and 10 seconds to start warming fluids. It can warm up to 2 liters of cold fluids on a single-charged battery.
According to the announcement, the US millitary tested the system’s intuitive setup, portability, and high performance through many trials before adding it to the US Department of Defence priority list, resulting to its regulatory approval.
This made °M Warmer System the third product on the priority list to win FDA 510(k) regulatory clearance. As a result, the system has been adopted to offer emergency medical services in hospitals, helicopters, and defense forces in combat situations across Australia and Europe.
°MEQU’s °M Warmer System is also compliant with the current Tactical Combat Casualty Care (TCCC) guidelines due to its portability, user-friendliness, and battery-powered warming system. These features make the system suitable for delivering IV/IO resuscitation fluids to severely injured patients when and where needed.
With FDA regulatory approval, °MEQU is looking to accelerate its activities in the US market, boosting its global presence.
