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Tuesday, October 26, 2021

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HomeFDAEuropean Medical Device Firm BrainCool AB Enters US Market with 510(k) Clearance...

European Medical Device Firm BrainCool AB Enters US Market with 510(k) Clearance from FDA for IQoolTM System for Temperature Management


Based in Lund, Sweden, Europe, BrainCool AB (publ) (AktieTorget: BRAIN) is a publicly traded medical device company focused on next-generation temperature management systems

BrainCool AB, a European medical device firm, has received 510(k) clearance from the US Food and Drug Administration (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. The IQool System quickly and effectively cools adult patients when clinically indicated using easy-to-apply non-stick adhesive pads prefilled with BCCOOL (a non-toxic and bacteria-static cooling agent) that are attached to an automated chiller. The IQool engages within seconds, allowing clinicians in a variety of settings to manage patient temperature quickly and effectively.

“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,” commented BrainCool CEO Martin Waleij.

 

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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