EMIT, a developer, manufacturer of products for the treatment and prevention of hypothermia, has received the US Food and Drug Administration 510(k) approval to market HypothermX HX100 device.
The HypothermX HX100 device is a patent protected portable fluid warming device designed to warm intravenous fluids, blood or blood products infused into a patient to prevent or treat trauma, environmental, procedure related or induced hypothermia.
EMIT founder, chairman and CEO Sheldon said HypothermX HX100 is a light weight (< 3.0 lbs), portable, long-term (>4 hours continuous use) solution which offers actual therapeutic warming in the field for injured patients.
"HypothermX HX100 is capable of warming up to 5 liters of saline introduced at 15 degrees C and 15 units of packed red blood cells introduced at 5 degrees C to 38 degrees C +/- 3 degrees C with an infusion rate between 50 ml/min and 200 ml/min and ambient conditions between 0 degrees C and 40 degrees C," Sheldon said.
"Our market clearance represents a milestone for the company and we will begin an sales and marketing campaign in the military and civilian market sectors this quarter."