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    Breaking News

    BrainCool AB Enters U.S. Market With FDA 510(k) Clearance for IQool Temperature Management System

    IQool System is a next-generation precision surface cooling system intended for temperature management.

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    Business Wire05.31.17
    European medical device firm BrainCool AB has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first product in the United States, the IQool 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.
     
    Based in Lund, Sweden, Europe, BrainCool AB is a publicly traded medical device company focused on next-generation temperature management systems. The technology platform both cools and warms patients using focused anatomical zones as opposed to whole body applications such as cooling blankets. BrainCool dramatically advances the temperature management standard of care by delivering a physically-targeted, speed-driven temperature management system designed to be easy to use and effective. The company currently markets a number of CE-marked devices in Europe addressing therapeutic hypothermia for cardiac arrest and stroke (BrainCool and RhinoChill), with products focused on oncology, traumatic brain injury and pain management currently in development.
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    • FDA Breakthrough Device Designation Awarded to BrainCool AB

      FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System

      The Cooral System was CE marked in June 2020 as an invasive medical device.
      Michael Barbella, Managing Editor 03.02.21

    • Mercury Biomed Awarded NIH Grant

      Mercury Biomed Awarded NIH Grant

      Funding will help company commercialize its patient warming technology.
      Mercury Biomed LLC 05.25.17

    • Medical Device Funding: Any Signs of Life?

      Medical Device Funding: Any Signs of Life?

      ...
      Ben Dunn, Managing Director, Covington Associates 05.01.17


    • GTCR Partners With Medtech Industry Veteran to Form Regatta Medical

      GTCR Partners With Medtech Industry Veteran to Form Regatta Medical

      Former Creganna Medical CEO to build new company through acquisitions and organic growth.
      GTCR 04.26.17

    • UL Acquires Emergo to Expand Medical Device Regulatory Services

      UL Acquires Emergo to Expand Medical Device Regulatory Services

      Will help customers navigate complex, constantly evolving regulatory requirements on a global basis.
      PR Newswire 04.26.17

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