IQcool Warm System receives FDA 510(k) clearance

30th May 2018

BrainCool AB

Enaie Azambuja

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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 regulation pads.

The IQool Warm System is a next-generation precision surface temperature regulation system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and torso.

The IQool Warm System quickly and effectively regulates body temperature in adult patients when clinically indicated using easy-to-apply non-stick adhesive pads prefilled with BCCOOL (a non-toxic and bacteriostatic cooling agent) that are attached to an automated temperature control unit.

The IQool Warm System engages within seconds, allowing clinicians in a variety of settings to manage patient temperature quickly and effectively.

BrainCool CEO Martin Waleij commented, "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."