EMIT Corporation Receives FDA 510(k) Clearance for HypothermX Blood and Fluid Warmer

▤ Summary

EMIT Corporation announced today that it has received U.S. Food and Drug Administration 510(k) clearance to market the 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. "HypothermX™ HX100 is the first truly light weight (< 3.0 lbs), portable, long-term (>4 hours continuous use) solution to offer actual therapeutic warming in the field for injured patients. EMIT Corporation is focused on the design, development, manufacture, and sale of devices and related products for the treatment and prevention of hypothermia. The HypothermX™ HX100 and ancillary products were invented by Charles Cox, Jr., MD and Brijesh Gill, MD and exclusively licensed from The University of Texas Health Science Center at Houston and The University of Texas at Austin following nearly $4.0 million of research and development funding provided by the United States Army Telemedicine and Advanced Technology Research Center.

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