The °MEQU warmer and power pack feature a user-friendly design. Credit: Business Wire / °MEQU.

Danish company °MEQU has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its portable blood and IV-fluid warming device, the °M Warmer System.

The °M Warmer System can assist military and civilian medical personnel in preventing hypothermia in patients experiencing haemorrhage by providing warmed transfusions and IV fluids at the point of injury, during transport, and in hospitals.

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Featuring a user-friendly design, the system aligns with the Tactical Combat Casualty Care (TCCC) guidelines on providing medical care.

These guidelines emphasise the importance of using battery-powered warming devices to administer IV/IO resuscitation fluids in combat conditions to mitigate hypothermia risks.

The system was developed in partnership with the Danish military and the Technical University of Denmark (DTU) to enhance the survival and recovery rates of critically injured patients.

Before receiving FDA clearance, the °M Warmer System completed extensive trials with US military units and helicopter emergency medical services, demonstrating its ease of use, portability and high performance.

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It has already been implemented in emergency medical services, helicopter emergency medical services, hospitals, and defence forces in Australia and Europe.

°MEQU founder and CEO Ulrik Krogh Andersen said: “We are proud to receive the FDA clearance, which is a major milestone for our company and the result of more than ten years of product development.

“With the clearance, the road is paved for a strong presence in the US market, and we are honoured to be able to help US healthcare professionals in their efforts to save lives with our °M Warmer System.”