European medical device developer BrainCool said this week it won FDA 510(k) clearance for its IQool next-generation surface cooling system, and will enter the US market for the 1st time with the device.
The IQool system won clearance with an indication for temperature reduction in adult patients, the company said..
The system focuses on managing temperatures in the head and neck region, thighs and torso, the company said, using non-stick adhesive pads filled with cooling agent attached to an automated chiller.
“Precise and tolerable temperature management can be critical in achieving positive patient outcomes in a large variety of clinical settings. The patented IQool System is designed to work with both sedated and conscious patients, and works with several independent cooling zones of the body to maximize its effectiveness,” CEO Martin Waleij said in a press release.