European medical device developer BrainCool said today it won FDA 510(k) clearance for its IQool Warm System with indications for thermal regulation to cool and rewarm adult patients.
The Swedish company said the newly cleared next-gen temperature regulation system is designed for temperature management with a focus on the head and neck, thighs and torso.
The system uses non-stick adhesive pads prefilled with a non-toxic and bacteriostatic cooling agent which are attached to an automated temperature control unit, which is intended to begin warming and cooling immediately, BrainCool said.
“We are very pleased to be moving into new clinical applications of our IQool System in the US to combine cooling and warming of patients quickly and effectively. The implementation of the warming function is essential to offset cooling when reaching target temperature quickly, and maintaining target temperature within narrow limits over time. The cooling process may be enhanced and the added effective warming component aims to add precision to temperature management. In addition to this new FDA clearance, we expect to present data for the product from an evaluation in Sweden and Germany at US scientific meetings this fall. Within the business area of brain cooling, BrainCool is collaborating with European researchers on our proprietary RhinoChill-system, which is currently CE-marked. We anticipate results in late 2018 and hope to be able to deliver this mobile cooling system to the US market soon,” CEO Martin Waleij said in a press release.
Last May, BrainCool said it won FDA 510(k) clearance for its IQool next-generation surface cooling system.