BrainCool AB has received 510(k) clearance from the FDA to market its second product in the United States, the IQool Warm System, with an indication for use of thermal regulation to cool and rewarm adult patients when clinically indicated. The system adds important features to the company’s first product, which was cleared by the FDA in May, 2017, with the indication to cool patients using its patented anatomically-targeted temperature regu...

European medical device firm BrainCool AB has received 510(k) clearance from the US FDA to market its first product in the United States, the IQoolTM System, with an indication for use of temperature reduction in adult patients when clinically indicated. The IQool System is a next-generation precision surface cooling system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and torso.