Gentherm Gets 510(k) Clearance for Patient Warming System
October 19, 2020
Gentherm Medical has obtained the FDA’s 510(k) marketing clearance for ASTOPAD, a warming system for prevention or treatment of hypothermia during surgery.
ASTOPAD uses an electronic controller and a selection of warming blankets, each with eight sensors for precise temperature control. Warming blankets can be placed over and under the patient and the temperature settings can be set individually.
The system has a proven track record as it has been used in hospitals outside the U.S. since 1989, the company said.