Denmark-based medical technology firm °MEQU has received the US Food and Drug Administration (FDA) 510(k) clearance for its °M Warmer System.
°M Warmer System is a portable blood and IV fluid warmer system designed for military and civilian use.
The patented design of the °M Warmer System offers portability and user-friendliness.
The device facilitates warming blood and IV-fluids at the point of injury, during transport, or in hospital settings. This capability reduces the risk of hypothermia in haemorrhaging patients, °MEQU claimed.
Originally developed in collaboration with the Danish military and the Technical University of Denmark (DTU), the °M Warmer System aims to combat hypothermia and enhance severely injured patients’ survival and recovery rates.
The device aligns with the tactical combat casualty care (TCCC) guidelines for providing medical care to injured military staff in combat conditions.
It emphasises the use of a battery-powered warming device to administer IV/IO resuscitation fluids and mitigate hypothermia risks.
°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 10 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.”
The regulatory clearance was based on various trials conducted along with US military units and helicopter emergency medical services.
The Danish MedTech company said that the results confirmed the °M Warmer System’s portability, ease of setup, and performance.
Furthermore, its inclusion in the US Department of Defense priority list led to FDA 510(k) clearance, marking it as the third prioritised product to receive such authorisation.
The adoption of the °M Warmer System spans various sectors, including helicopter emergency medical services, emergency medical services, hospitals, and defense forces across Europe and Australia.
